SonoSite M-Turbo Ultrasound System

User Guide Manufacturer EC Authorized Representative Australia Sponsor FUJIFILM SonoSite, Inc. FUJIFILM SonoSite B.V. FUJIFILM SonoSite Australasia Pty Ltd 21919 30th Drive SE Joop Geesinkweg 140 114 Old Pittwater Road Bothell, WA 98021 USA 1114 AB Amsterdam, BROOKVALE, NSW, 2100 T: 1-888-482-9449 or 1-425-951- The Netherlands Australia 1200 F: 1-425-951-1201

Federal (United States) law restricts this device to sale by or on the order of a Caution physician.

SonoSite M-Turbo, SonoHD2, SonoMB, SonoSite and the SONOSITE logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a registered trademark of FUJIFILM Corporation. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation. DICOM is a registered trademark of the National Electrical Manufacturers Association.

FUJIFILM is a registered and unregistered trademark of FUJIFILM Corporation in various jurisdictions.

The FUJIFILM SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: Patents: US 9,895,133; US 9,671,491; US 9,151,832; US 8,861,822; US 8,500,647; US 8,398,408; US 8,213,467; US 8,137,278; US8,088,071; US 8,066,642; US 7,849,250; US D625,015; US D625,014; US 7,740,586; US 7,591,786; US 7,588,541; US 7,534,211; US D559,390; US D544,962; US D538,432; US 7,169,108; US 6,962,566; US D509,900; US 6,648,826; US 6,569,101; US 6,471,651; US 6,364,839; CA 2372152; CA 2371711; CN ZL201180028132.X; CN ZL200880106592.8; EP 2187813 validated in FR and GB; EP 1589878 validated in DE, FR, and GB; EP 1552792 validated in DE, FR, and GB; EP 1180971 validated in DE and GB; EP 1180970 validated in DE, FR, and GB; JP 6258367; JP 5972258; JP 5894571; JP 5452491.

Part number: P07662-06

Publication date: June 2018 Copyright © 2018 FUJIFILM SonoSite, Inc. All rights reserved.

2 1. Introduction

Changes in this version ...... 1-2 Document conventions ...... 1-2 Getting help ...... 1-3

2. Getting Started

About the system ...... 2-1 Preparing the system ...... 2-3 Installing or removing the battery ...... 2-3 Using AC power and charging the battery ...... 2-5 Turning the system on or off ...... 2-6 Connecting transducers ...... 2-6 Inserting and removing USB storage devices ...... 2-8 System controls ...... 2-9 Screen layout ...... 2-11 Annotation and text ...... 2-13 General interaction ...... 2-14 Touchpad and cursor ...... 2-14 On-screen options ...... 2-14 Preparing transducers ...... 2-16 Training videos ...... 2-17 Intended uses ...... 2-18

3. System Setup

Displaying the setup pages ...... 3-1 Restoring default settings ...... 3-1 A & B key and footswitch setup ...... 3-1 Administration setup ...... 3-2 Security settings ...... 3-2 User setup ...... 3-3 Exporting or importing user accounts ...... 3-4 CONTENTS Exporting and clearing the event log ...... 3-5 Logging in as user ...... 3-6 Choosing a secure password ...... 3-6 Annotations setup ...... 3-6 Audio and battery setup ...... 3-8

i Cardiac calculations setup ...... 3-8 Connectivity setup ...... 3-8 Date and time setup ...... 3-9 Display information setup ...... 3-9 IMT calculations setup ...... 3-10 Network status setup ...... 3-10 OB calculations setup ...... 3-10 OB custom measurements setup ...... 3-11 OB custom tables setup ...... 3-12 Presets setup ...... 3-13 System information setup ...... 3-14 USB devices setup ...... 3-14 Specifying a file format for exported images ...... 3-14 Including private tags ...... 3-15 Limitations of JPEG format ...... 3-15 eFilm Lite image-viewer ...... 3-15

4. Imaging

Imaging modes ...... 4-1 2D imaging ...... 4-1 M Mode imaging ...... 4-5 CPD and Color Doppler imaging ...... 4-6 PW and CW Doppler imaging ...... 4-7 Adjusting depth and gain ...... 4-10 Freezing, viewing frames, and zooming ...... 4-11 Needle visualization ...... 4-12 About MBe ...... 4-12 Imaging modes and exams available by transducer ...... 4-14 Annotating images ...... 4-17 Placing text on an image ...... 4-17 Resetting the home position ...... 4-18 Placing an arrow on an image ...... 4-18 Placing a pictograph on an image ...... 4-19 Patient information form ...... 4-19 Images and clips ...... 4-21 Saving images and clips ...... 4-21 Reviewing patient exams ...... 4-23 Printing, exporting, and deleting images and clips ...... 4-26 ECG monitoring ...... 4-27

5. Measurements and Calculations

Measurements ...... 5-1 Working with calipers ...... 5-2 2D measurements ...... 5-2

ii M Mode measurements ...... 5-4 Doppler measurements ...... 5-5 General calculations ...... 5-8 Unexpected data loss ...... 5-8 Calculations menu ...... 5-8 Performing and saving measurements in calculations ...... 5-9 Displaying, repeating, and deleting saved measurements in calculations ...... 5-9 EMED calculations ...... 5-10 Percent reduction calculations ...... 5-11 Volume calculations ...... 5-13 Exam-based calculations ...... 5-16 Measurement publications and terminology (cardiac) ...... 5-30 Gynecology (Gyn) calculations ...... 5-31 IMT calculations ...... 5-32 OB calculations ...... 5-36 Small parts calculations ...... 5-40 Transcranial Doppler and orbital calculations ...... 5-41 Vascular calculations ...... 5-44 Patient report ...... 5-45 Vascular and cardiac patient reports ...... 5-46 TCD patient report ...... 5-47 OB patient report ...... 5-47 EMED worksheets ...... 5-48 MSK worksheets ...... 5-49

6. References

Measurement accuracy ...... 6-1 Sources of measurement errors ...... 6-3 Measurement publications and terminology ...... 6-3 Cardiac references ...... 6-4 Obstetrical references ...... 6-12 Gestational age tables ...... 6-13 Growth analysis tables ...... 6-16 Ratio calculations ...... 6-18 General references ...... 6-18

7. Cleaning and Disinfecting

Before getting started ...... 7-1 Determining the required cleaning and disinfecting level ...... 7-2 Spaulding classifications ...... 7-3 Clean and disinfect system and transducer to a high level (semi-critical uses) ...... 7-3 Clean and disinfect system and transducer to a low level (non-critical uses) ...... 7-8 Storing the transducer ...... 7-10 Transporting the transducer ...... 7-11

iii Cleaning the stand ...... 7-12 Cleaning the footswitch ...... 7-12 Cleaning and disinfecting accessories ...... 7-13

8. Troubleshooting and Maintenance

Troubleshooting ...... 8-1 Software licensing ...... 8-2 Maintenance ...... 8-4 Cleaning and disinfecting the battery ...... 8-4

9. Safety

Ergonomic safety ...... 9-1 Position the system ...... 9-2 Position yourself ...... 9-2 Take breaks, exercise, and vary activities ...... 9-3 Electrical safety classification ...... 9-4 Electrical safety ...... 9-4 Equipment safety ...... 9-7 Battery safety ...... 9-8 Clinical safety ...... 9-10 Hazardous materials ...... 9-11 Electromagnetic compatibility ...... 9-11 Separation distance ...... 9-13 Compatible accessories and peripherals ...... 9-14 Guidance and manufacturer’s declaration ...... 9-16 Manufacturer’s declaration ...... 9-16 ALARA principle ...... 9-19 Applying ALARA ...... 9-20 Direct controls ...... 9-20 Indirect controls ...... 9-21 Receiver controls ...... 9-21 Acoustic artifacts ...... 9-21 Guidelines for reducing MI and TI ...... 9-22 Output display ...... 9-23 MI and TI output display accuracy ...... 9-25 Factors that contribute to display uncertainty ...... 9-25 Related guidance documents ...... 9-25 Transducer surface temperature rise ...... 9-26 Acoustic output measurement ...... 9-27 In Situ, derated, and water value intensities ...... 9-27 Tissue models and equipment survey ...... 9-28 Acoustic output tables ...... 9-29 Terms used in the acoustic output tables ...... 9-73 Acoustic measurement precision and uncertainty ...... 9-74

iv Labeling symbols ...... 9-75

10. Specifications

Dimensions ...... 10-1 System ...... 10-1 Display ...... 10-1 Supported transducers ...... 10-1 Imaging modes ...... 10-2 Image and clip storage ...... 10-2 Accessories ...... 10-2 Peripherals ...... 10-3 Operating ...... 10-3 Shipping and storage ...... 10-3 Electrical ...... 10-4 Battery ...... 10-4 Standards ...... 10-4 Electromechanical safety standards ...... 10-4 EMC standards classification ...... 10-5 Acoustic standards ...... 10-5 Biocompatibility standards ...... 10-5 Airborne equipment standards ...... 10-5 DICOM standard ...... 10-5 HIPAA ...... 10-6

11. IT Network

Functions ...... 11-1 Network for connecting the device ...... 11-1 Specifications for the connection ...... 11-1

A. Glossary

Terms ...... A-1 Abbreviations ...... A-3

B. Index

v vi Introduction

This SonoSite M-Turbo Ultrasound System User Guide provides information on preparing and using the SonoSite M-Turbo ultrasound system and on cleaning and disinfecting the system, transducers, and accessories. It also provides system specifications and safety and acoustic output information.

The user guide is written for a reader familiar with ultrasound techniques. It does not provide training in sonography or clinical practices. Before using the system, you must have ultrasound training.

Refer to the applicable FUJIFILM SonoSite accessory user guide for information on using accessories and peripherals. Refer to the manufacturer’s instructions for specific information about peripherals. CHAPTER 1

Introduction 1-1 Changes in this version

Change Description

Warnings and Updated and added warnings and cautions from compliance testing to cautions the Safety chapter.

Cleaning and Added the Cleaning and Disinfecting chapter and removed the Disinfecting Cleaning section from the Troubleshooting and Maintenance chapter. chapter

IT Network Added the new IT Network chapter. chapter

EMC standard Updated the EMC standards classification.

Incorporated P16206-02 User Guide P20052-03 Erratas and P20272-08 Supplements P19888-02 P15653-06

Document conventions

The user guide follows these conventions:

A WARNING describes precautions necessary to prevent injury or loss of life.

A Caution describes precautions necessary to protect the products.

A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. Single-step procedures begin with .

For a description of labeling symbols that appear on the product, see a“Labeling symbols” on page 9-75 in the user guide.

1-2 Introduction Getting help

For technical support, please contact FUJIFILM SonoSite as follows:

Phone 877-657-8118 (U.S. or Canada)

Phone 425-951-1330, or call your local representative (outside U.S. or Canada)

Fax 425-951-6700

Email [email protected]

Web www.sonosite.com

Europe Service Center Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451

Asia Service Center +65 6380-5581

Printed in the U.S.

Introduction 1-3 1-4 Introduction Getting Started

About the system

The M-Turbo ultrasound system is a portable, software-controlled device using all-digital architecture. The system has multiple configurations and feature sets used to acquire and display high-resolution, real-time ultrasound images. Features available on your system depend on system configuration, transducer, and exam type.

A license key is required to activate the software. On occasion, a software upgrade may be required. FUJIFILM SonoSite provides a USB device containing the software. One USB device can be used to upgrade multiple systems. CHAPTER 2

Getting Started 2-1 3

4 1

2

Figure 2-1 System front features: (1) Control panel, (2) Handle, (3) Display, (4) USB ports for storage, updates, importing, and exporting

1 23 4

Figure 2-2 System back connectors: (1) DC input connector, (2) I/O connector, (3) Battery, and (4) ECG connector

To use the ultrasound system 1 Attach a transducer.

2 Turn the system on. (For power switch location, see “System controls” on page 2-9.)

3 Press the Patient key, and complete the patient information form.

4 Press an imaging mode key: 2D, M Mode, Color, or Doppler

2-2 Getting Started Preparing the system

Installing or removing the battery

To avoid data loss and conduct a safe system shutdown, always keep a battery in the system.

WARNINGS To avoid injury to the operator and prevent damage to the ultrasound system, inspect the battery for leaks before installing the battery.

To avoid data loss and conduct a safe system shutdown, always keep a battery in the system.

To install the battery 1 Disconnect the power supply from the ultrasound system.

2 Remove the system from the mini-dock (if present) and turn it upside down.

3 Place the battery into the battery compartment, at a slight angle. See Figure 2-3 on page 2-4.

4 Slide the battery forward until it locks into place.

Getting Started 2-3 5 Push down on the two locking levers to secure the battery.

Locking

Figure 2-3 Install the battery

2-4 Getting Started To remove the battery 1 Disconnect the power supply from the ultrasound system.

2 Remove the system from the mini-dock (if present) and turn it upside down.

3 Pull up the two locking levers.

4 Slide the battery back.

5 Lift the battery from the compartment.

Using AC power and charging the battery

When using AC power, position the system to allow easy access to disconnect it.

The battery charges when the system is connected to the AC power supply. A fully discharged battery recharges in less than five hours. The system can run on AC power and you can charge the battery if the AC power is connected directly to the system mini-dock, or docking system.

The system can run on battery power for up to two hours, depending on the imaging mode and display brightness. When running on battery power, the system may not restart if the battery is low. To continue, connect the system to AC power.

WARNINGS Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Specifications” on page 9-25. Plug the system only into a grounded hospital-grade outlet. Use only power cords provided by FUJIFILM SonoSite with the system.

To operate the system using AC power 1 Connect the DC power cable from the power supply to the connector on the system. Refer to Figure 2-2 on page 2-2. 2 Push the cable in firmly to ensure a secure connection. 3 Connect the AC power cord to the power supply and a hospital-grade electrical outlet.

Getting Started 2-5 To separate the system (and any connected equipment) from a supply mains

Caution The equipment is not provided with an AC mains power switch. To disconnect the equipment from mains, use the appliance coupler or mains plug on the power supply cord. Install the ultrasound system in a place where you can easily connect or disconnect the AC power cord. Disconnecting only the DC power cable from the system does not separate the system from the supply mains.

 Disconnect the AC power cord from the power supply or (alternatively, if using a stand) from the AC adapter on the stand base.

Turning the system on or off

Caution Do not use the system if an error message appears on the image display: Note the error code; call FUJIFILM SonoSite or your local representative; and turn off the system by pressing and holding the power key until the system powers down.

To turn the system on or off  Press the power switch. (See “System controls” on page 2-9.) To wake up the system

To conserve battery life while the system is on, the system goes into sleep mode if the lid is closed or if the system is untouched for a preset time. To adjust the time for sleep delay, see “Audio and battery setup” on page 3-8.

 Press a key, touch the touchpad, or open the lid.

Connecting transducers

WARNING To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in a docking system or on a flat, hard surface to allow airflow past the connector.

Caution To avoid damaging the transducer connector, do not allow foreign material in the connector.

To connect a transducer 1 Remove the system from the mini-dock (if present), and turn it upside down.

2 Pull the transducer latch up, and rotate it clockwise.

2-6 Getting Started 3 Align the transducer connector with the connector on the bottom of the system.

4 Insert the transducer connector into the system connector.

5 Turn the latch counterclockwise.

6 Press the latch down, securing the transducer connector to the system.

Figure 2-4 Connect the transducer

To remove a transducer

1 Pull the transducer latch up, and rotate it clockwise.

Getting Started 2-7 2 Pull the transducer connector away from the system

Inserting and removing USB storage devices

Images and clips are saved to internal storage and are organized in a sortable patient list. You can archive the images and clips from the ultrasound system to a PC using a USB storage device or Ethernet connection. Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the device and view them on your PC.

There are two USB ports on the system and one on the mini-dock. For additional USB ports, you can connect a USB hub into any USB port.

Note The system does not support password-protected USB storage devices. Make sure that the USB storage device you use does not have password protection enabled.

If you attach a USB device to the system, wait at least 30 seconds before removing it or attaching another USB device. Similarly, if you remove a USB device from the system, wait at least 30 seconds before reattaching it or attaching another USB device.

Attaching or removing USB devices (for example, a USB printer or USB storage device) too quickly may cause the system to stop responding and to display a blue screen with the Maintenance and

Attention icons.

2-8 Getting Started System controls

1 14

2 15

3 4 16 5 17 18 6 19 7

20

8 910 11 12 13

1 Power switch Turns system on and off. 2 Alphanumeric keys Use to enter text and numbers. 3 Annotation keys See “Alphanumeric keyboard” on page 2-13. 4 ZOOM Magnifies the image 100%. 5DEPTH UP, Decreases and increases imaging depth. DEPTH DOWN 6 AUTO GAIN Adjusts gain automatically. 7Gain

Near Adjusts the gain applied to the near field of the image.

Far/ In live imaging, adjusts the gain applied to the far field of the image. Angle correction On a frozen PW Doppler image, adjusts the angle.

Gain/ In live imaging, adjusts the overall gain applied to the entire image. Cine buffer On a frozen image, moves the cine buffer.

Getting Started 2-9 8 AC power indicator A steady light indicates that AC power is connected. A flashing light indicates that the system is asleep. 9CALIPER Displays calipers on-screen for measuring. CALCS Turns the calculations menu on and off. 10 Touchpad Selects, adjusts, and moves items on-screen. 11 FREEZE Stops live imaging and displays a frozen image. 12 SAVE Saves an image to internal storage. If configured, also saves calculations to the report. See “Presets setup” on page 3-13. 13 CLIP Saves a clip to internal storage. 14 Control keys Control on-screen options. 15 Forms SETUP Displays the system settings. REPORT Accesses the patient report and EMED worksheets. REVIEW Accesses the patient list, saved images, and archiving functions. PATIENT Accesses patient information. 16 EXAM Opens exam menu. 17 A & B shortcut keys Keys that you can program to perform common tasks. 18 SET Sets a trace measurement. SELECT Used with the touchpad to select items on-screen. Also switches between Color and Doppler options, calipers for measurement, pictograph-marker position and angle, frozen images in duplex and dual screens, and arrow position and orientation. SAVE CALC Saves calculations and their measurements to the patient report. 19 UPDATE Toggles between dual and duplex screens and imaging modes in M Mode and Doppler (for example, between D-line and Doppler spectral trace). 20 Imaging modes M MODE Turns M Mode on, toggles between M-line and M Mode trace. DOPPLER Turns Doppler on, toggles between D-line and Doppler trace. COLOR Turns CPD/Color on and off. 2D Turns 2D on.

2-10 Getting Started Screen layout 9 1 2 3

4 10

5

6

11

7 8

Figure 2-5 Screen layout

1 Mode data area Current imaging mode information (for example, Gen, Res, THI, and PW). 2 Orientation marker Provides indication for image orientation. In dual and duplex images, the orientation marker is green on the active screen. 3 Text Text entered using keyboard. 4 Pictograph Pictograph to indicate anatomy and transducer position. You can select anatomy and screen location. 5 Calculations menu Contains available measurements. 6 Image Ultrasound image. 7 Measurement and Current data on measurements and calculations. calculations data area 8 On-screen options Options available in the current context. 9 Patient header Includes current patient name, ID number, institution, user, and date/time. 10 System status Information on system status (for example, exam type, transducer, AC connected, battery charging, and USB). 11 Depth marker Marks in .5 cm, 1 cm, and 5 cm increments depending on depth.

Getting Started 2-11 WARNINGS To avoid damaging the USB storage device and losing patient data from it, observe the following: Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break.

Caution If the USB icon does not appear in the system status area on-screen, the USB storage device may be defective or password-protected. Turn the system off, and replace the device.

To insert a USB storage device  Insert the USB storage device into any USB port on the system or mini-dock. See Figure 2-1 on page 2-2. The USB storage device is ready when the USB icon appears. To view information about the device, see “Inserting and removing USB storage devices” on page 2-8. To remove a USB storage device

Removing the USB storage device while the system is exporting to it may cause the exported files to be corrupted or incomplete.

1 Wait five seconds after the USB animation stops.

2 Remove the USB storage device from the port.

2-12 Getting Started Annotation and text

Alphanumeric keyboard

10 1 2 11 3 4

567 8 9

1 TAB Moves cursor among fields in the forms, and tabs between text position in dual screens.

2 CAPS LOCK Sets the keyboard to capital letters.

3 SHIFT Allows entry of capitalized characters and international characters.

4 TEXT Turns the keyboard on and off for text entry.

5 PICTO Turns pictographs on and off.

6 ARROW Displays an arrow graphic that can be moved and rotated within the image area.

7 SPACEBAR Turns the keyboard on for text entry. In text entry, adds a space.

8 DELETE Removes all text from the screen during text entry and when not measuring.

9 ARROW Moves highlighted selection in calculations menu, move cursor one space when KEYS entering text, move caliper position, move cine buffer forward and backward, and move among pages in image review and reports.

10 BACKSPACE Removes the character left of the cursor in text-entry mode.

11 ENTER Moves cursor among fields in forms and saves calculations to report.

Getting Started 2-13 General interaction

Touchpad and cursor

Use the touchpad to adjust and move objects on-screen. The touchpad controls caliper position, CPD or Color box position and size, the cursor, and more. The arrow keys control much of the same functionality as the touchpad.

Make sure to keep the touchpad dry while in use. Moisture on the touchpad can cause the cursor to respond erratically.

The cursor appears in the Setup pages, the Patient Information form, and Patient report. You control the cursor through the touchpad. For example, in the Patient Information form, place the cursor over the last name field and press the SELECT key to activate that field. Additionally, you can use the cursor to select check boxes and items in lists.

On-screen options

The on-screen options let you make adjustments and select settings. The options available depend on context.

Each option is controlled by the pair of keys below it. Depending on the option, the control keys function in one of four ways:

Cycle Moves through a list of settings continuously. The upper control key cycles upward. The lower control key cycles downward.

Up-Down Moves through a list of settings, stopping at the top or bottom. The upper control key moves upward. The lower control key moves downward. By default, a beep sounds when you reach either end of the range. (See “Audio and battery setup” on page 3-8.)

On-Off Turns a feature on or off. You can press either control key. In forms, you can instead select the option by using the touchpad and the SELECT key.

Action Performs an action. You can press either control key. Or you can instead select the option by using the touchpad and the SELECT key.

Figure 2-6 On-screen options (2D imaging shown)

2-14 Getting Started Symbols

You can enter symbols and special characters in select fields and forms. The symbols and special characters available depend on context.

Patient information form: Last, First, Middle, Patient ID, Accession, Indications, Procedure ID, User, Reading Dr., Referring Dr., and Institution fields

DICOM or SiteLink configuration page: Alias and AE Title fields

A & B key, footswitch setup page: Text field

Text mode (imaging): Annotation field

Figure 2-7 Symbols dialog box

To enter symbols or special characters 1 Select the field, and then select Symbols.

2 Select the desired symbol or character.

You can also press the keys on the keyboard. 3 Select OK.

Getting Started 2-15 Preparing transducers

WARNINGS Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber.

Some gels and sterilants can cause an allergic reaction on some individuals.

Cautions To avoid damage to the transducer, use only gels recommended by FUJIFILM SonoSite. Using gels other than the one recommended by FUJIFILM SonoSite can damage the transducer and void the warranty. If you have questions about gel compatibility, contact FUJIFILM SonoSite or your local representative.

FUJIFILM SonoSite recommends that you clean transducers after each use. See “Cleaning and Disinfecting” on page 7-1.

Acoustic coupling gel must be used during exams. Although most gels provide suitable acoustic coupling, some gels are incompatible with some transducer materials. FUJIFILM SonoSite recommends Aquasonic® gel and provides a sample with the system.

For general use, apply a liberal amount of gel between the transducer and the body. For invasive or surgical use, be sure to follow the sterilization instructions described in “Cleaning and Disinfecting” on page 7-1.

WARNING To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure.

To apply a transducer sheath

FUJIFILM SonoSite recommends the use of market-cleared transducer sheaths for intracavitary or surgical applications.To lessen the risk of contamination, apply the sheath only when you are ready to perform the procedure.

1 Place gel inside the sheath.

2 Insert the transducer into the sheath.

3 Pull the sheath over the transducer and cable until the sheath is fully extended.

4 Secure the sheath using the bands supplied with the sheath.

2-16 Getting Started 5 Check for and eliminate bubbles between the face of the transducer and the sheath.

Bubbles between the face of the transducer and the sheath may affect the ultrasound image.

WARNING Inspect the sheath to ensure that there are no holes or tears.

Training videos

The FUJIFILM SonoSite® Education Key™ training videos are an optional feature.

To display the list of videos 1 Insert the Education Key USB device into a USB port on the system.

2 Press the REVIEW key.

3 If there is an active exam, select List on-screen.

4 Select the Videos tab.

5 If the list does not appear, select the correct USB device:

a Select Select USB. b In the Select USB device for media playback dialog box, select the Education Key USB device (“Training” appears under Type), and then select Select.

Note Image gallery is an unsupported feature.

To view a video 1 Display the list of videos.

2 Select the video.

3 Select View on-screen.

The video begins playing. 4 Select any of the following, as needed:

 Adjusts the volume. The higher the number, the louder the sound. Zero is mute. Back Rewinds the video 10 seconds. Pause Pauses the video.

Getting Started 2-17 Play Resumes playing a paused video. Forward Advances the video 10 seconds. To exit a video  Select one of the following: List to return to the video list. Done to return to 2D imaging.

Intended uses

This system transmits ultrasound energy into various parts of the patient’s body to obtain ultrasound images, as follows.

For the intended transducer and imaging modes for each exam type, see “Imaging modes and exams available by transducer” on page 4-14.

Abdominal imaging applications You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures for the presence or absence of pathology transabdominally.

Cardiac imaging applications You can assess the heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size for the presence or absence of pathology.

In addition, you can identify the presence and location of fluid around the heart and lungs, use to assist in pericardiocentesis and thoracentesis procedures, visualize blood flow through cardiac valves, and detect normal lung motion for the presence or absence of pathology.

You can obtain the patient’s electrocardiogram (ECG). The ECG is used for timing of cardiac events.

WARNING The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.

Gynecology and infertility imaging applications You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence of pathology transabdominally or transvaginally.

Interventional imaging applications You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, breast, and neurological surgery.

2-18 Getting Started Obstetrical imaging applications You can assess the fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures for the presence or absence of pathology transabdominally or transvaginally. CPD and color imaging are intended for high-risk pregnant women. High-risk pregnancy indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.

WARNINGS To prevent injury or misdiagnosis, do not use this system for Percutaneous umbilical blood sampling (PUBS) or in vitro fertilization (IVF) The system has not been validated to be proven effective for these two uses.

CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of intrauterine growth retardation (IUGR).

Pediatric and neonatal imaging applications You can assess the pediatric and neonatal abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures for the presence or absence of pathology.

Prostate imaging applications You can assess the prostate and surrounding anatomical structures for the presence or absence of pathology.

Superficial imaging applications You can assess the breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, ophthalmic structures, and surrounding anatomical structures for the presence or absence of pathology. You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

WARNING To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

Transcranial imaging applications You can assess the anatomical structures and vascular anatomy of the brain for presence or absence of pathology. You can use imaging temporally, trans-occipitally, or trans-orbitally.

WARNING To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

Getting Started 2-19 Vascular imaging applications You can assess the carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or absence of pathology.

2-20 Getting Started System Setup

The system setup pages let you customize the system and set preferences.

Displaying the setup pages

To display a setup page 1 Press the SETUP key.

2 Select the setup page under Setup Pages.

To return to imaging from a setup page, select Done on-screen.

Restoring default settings

To restore default settings for a setup page  On the setup page, select Reset on-screen. To restore all default settings 1 Turn the system off.

2 Connect the system to AC power. (See “Electrical safety” on page 9-4.)

3 Simultaneously press 1 and the power key.

The system beeps several times.

A & B key and footswitch setup

On the A & B key, footswitch setup page, you can program the shortcut keys and footswitch to perform common tasks. Select from the following lists: CHAPTER 3

System Setup 3-1 A key, B key The function of the shortcut keys. By default, the A shortcut key is set to Print and the B shortcut key is set to Record. The shortcut keys are below the alphanumeric keypad.

Footswitch (L), Footswitch (R) The function of the left and right footswitches: Save Clip, Record, Freeze, Save Image, or Print.

To connect the footswitch

The FUJIFILM SonoSite footswitch allows hands-free operation with a customizable two-pedal footswitch. The footswitch is an optional feature.

WARNING To avoid contamination, do not use the footswitch in a sterile environment. The footswitch is not sterilized.

1 Connect the footswitch USB cable to the USB port on the system or mini-dock.

2 On the A & B key, footswitch setup page, select a function for the left and right footswitches.

Administration setup

On the Administration setup page, you can configure the system to require users to log in and enter passwords. Required login helps protect patient data. You can also add and delete users, change passwords, import and export user accounts, and view the event log.

Security settings

WARNING Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the European Union Data Protection Directive (95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information.

Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected, stored, reviewed, and transmitted on the system.

To log in as administrator 1 On the administration setup page, type Administrator in the Name box.

3-2 System Setup 2 Type the administrator password in the Password box.

If you don’t have the administrator password, contact SonoSite. (See “Getting help” on page 1-3.) 3 Select Login.

To log out as administrator  Turn off or restart the system. To require user login

You can set the system to display the user login screen at startup.

1 Log in as Administrator.

2 In the User Login list, select On.

On requires a user name and password at startup. Off allows access to the system without a user name and password. To change the administrator password or let users change passwords 1 Log in as administrator.

2 Under User List, select Administrator.

3 Do any of the following:

Change the administrator password: Under User Information, type the new password in the Password box and Confirm box. (See “Choosing a secure password” on page 3-6.) Let users change their passwords: Select the Password changes check box. 4 Select Save.

User setup

To add a new user 1 Log in as administrator.

2 Select New.

3 Under User Information, fill in the Name, Password, and Confirm boxes. (See “Choosing a secure password” on page 3-6.)

4 (Optional) In the User box, type the user’s initials to display them in the patient header and the User field in the patient information form.

System Setup 3-3 5 (Optional) Select the Administration Access check box to allow access to all administration privileges.

6 Select Save.

To modify user information 1 Log in as administrator.

2 Under User List, select the user.

3 Under User Information, make changes as desired.

4 Select Save.

Any change to the user name replaces the previous name.

To delete a user 1 Log in as administrator.

2 Under User List, select the user.

3 Select Delete.

4 Select Yes.

To change a user password 1 Log in as administrator.

2 In the User List, select the user.

3 Type the new password in the Password box and Confirm box.

4 Select Save.

Exporting or importing user accounts

The export and import commands let you configure multiple systems and back up user account information.

To export user accounts 1 Insert a USB storage device.

2 Log in as administrator.

3 Select Export on-screen. A list of USB devices appears.

3-4 System Setup 4 Select the USB storage device, and select Export.

All user names and passwords are copied to the USB storage device. Passwords are encrypted. To import user accounts 1 Insert the USB storage device that contains the accounts.

2 Log in as administrator.

3 Select Import on-screen.

4 Select the USB storage device, and select Import.

5 Restart the system.

All user names and passwords on the system are replaced with the imported data.

Exporting and clearing the event log

The event log collects errors and events and can be exported to a USB storage device and read on a PC.

To display the event log 1 Log in as administrator.

2 Select Log on-screen.

The event log appears.

To return to the previous screen, select Back.

To export the event log

The event log and the DICOM network log have the same file name (log.txt). Exporting either one to a USB storage device overwrites any existing log.txt file.

1 Insert a USB storage device.

2 Select Log and then select Export on-screen.

A list of USB devices appears. 3 Select the USB storage device, and select Export.

The event log is a text file that you can open in a text-editing application (for example, Microsoft Word or Notepad).

System Setup 3-5 To clear the event log 1 Display the event log.

2 Select Clear on-screen.

3 Select Yes.

Logging in as user

If user login is required, the user login screen appears when you turn on the system.

To log in as user 1 Turn on the system.

2 In the User Login screen, type your name and password, and select OK.

To log in as guest

Guests can scan but can’t access system setup and patient information.

1 Turn on the system.

2 In the User Login screen, select Guest.

To change your password 1 Turn on the system.

2 In the User Login screen, select Password.

3 Type your old and new passwords, confirm the new password, and then select OK.

Choosing a secure password

To ensure security, choose a password that contains uppercase characters (A-Z), lowercase characters (a-z), and numbers (0-9). Passwords are case-sensitive.

Annotations setup

On the Annotations setup page, you can customize predefined labels and set the preference for managing text when unfreezing images.

For instructions to annotate images, see “Annotating images” on page 4-17.

3-6 System Setup To predefine a label group

You can specify which labels are available for an exam type when annotating an image. (See “Annotating images” on page 4-17.)

1 In the Exam list on the Annotations setup page, select the exam type whose labels you want to specify.

2 For Group, select A, B, or C for the label group you want associated with that exam.

The preset labels appear for the selected group.

3 Do any of the following:

Add a custom label to the group: Type the label in the Text box, and select Add. Rename a label: Select the label, type the new name in the Text box, and select Rename. Move a label within the group: Select the label, and then select the on-screen up or down arrow. Delete a label from a group: Select the label, and select Delete. You can use symbols in labels. See “Annotation and text” on page 2-13. To specify text retention when unfreezing

You can specify which text to keep when you unfreeze an image or change the imaging layout.

 In the Unfreeze list on the Annotations setup page, select Keep All Text, Keep Home Text, or Clear All Text. The default setting is Keep All Text. For information on setting the home position, see “Resetting the home position” on page 4-18. To export predefined label groups 1 Insert a USB storage device.

2 On the Annotations setup page, select Export.

A list of USB devices appears. 3 Select the USB storage device, and select Export.

A copy of all predefined label groups for all exams saves to the USB storage device.

To import predefined label groups 1 Insert the USB storage device that contains the label groups.

2 On the Annotations setup page, select Import on-screen.

System Setup 3-7 3 Select the USB storage device, and then select Import.

4 Select Done in the dialog box that appears.

All predefined label groups for all exams are replaced with those from the USB storage device.

Audio and battery setup

On the Audio, Battery setup page, you can select options in the following lists:

Key click Select On or Off for keys to click when pressed.

Beep alert Select On or Off for the system to beep when saving, warning, starting, or shutting down.

Sleep delay Select Off, or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode.

Power delay Select Off, or 15 or 30 minutes to specify the period of inactivity before the system automatically turns off.

Cardiac calculations setup

On the Cardiac Calculations setup page, you can specify measurement names that appear in the Tissue Doppler Imaging (TDI) calculations menu and on the report page.

See also “Cardiac calculations” on page 5-16.

To specify cardiac measurement names  Under TDI Walls on the Cardiac Calculations setup page, select a name for each wall.

Connectivity setup

On the Connectivity setup page, you specify options for using non-USB devices and for alerts when internal storage is full. You also import wireless certificates and specify settings (including Transfer Mode and Location) for SiteLink™ Image Manager and DICOM®, which are optional features. For SiteLink issues, refer to the SiteLink Image Manager user guide. For DICOM issues, such as storage commitment, archivers, and MPPS, refer to Sending and Receiving DICOM Data on SonoSite Systems.

To configure the system for a printer 1 Set up the printer hardware. (See instructions included with the printer or docking system.)

2 In the Printer list on the Connectivity setup page, select the printer.

3-8 System Setup To configure the system for a DVD recorder, PC, or serial bar code scanner 1 On the Connectivity setup page, do the following:

(DVD recorder) In the Video Mode list, select the video standard: NTSC or PAL. In the Serial Port list, select the peripheral. Computer (PC) allows patient report data to be sent as ASCII text from the system to a PC. The PC must have third-party software to acquire, view, or format the data into a report. Check the compatibility of your software with SonoSite technical support.

Note Because these peripherals use the same RS-232 connector on the mini-dock, you can connect only one of them at a time.

2 Restart the system.

3 Attach a serial cable (RS-232) from the serial port on the mini-dock or docking system to the peripheral.

To receive storage alerts  On the Connectivity setup page, select Internal Storage Capacity Alert. The system displays a message if internal storage is near capacity when you end an exam. The system then deletes archived patient exams if specified in DICOM.

Date and time setup

WARNING To obtain accurate obstetrics calculations, an accurate date and time are critical. Verify that the date and time are accurate before each use of the system. The system does not automatically adjust for daylight saving time changes.

To set the date and time  On the Date and Time setup page, do the following: In the Date box, type the current date. In the Time box, type the current time in 24 hour format (hours and minutes).

Display information setup

On the Display Information setup page, you can specify which details appear on-screen during imaging. You can select settings in the following sections:

Patient Header Information that appears in the patient header.

Mode Data Imaging information.

System Setup 3-9 System Status System status information.

IMT calculations setup

On the IMT Calculations setup page, you can customize the IMT calculations menu. You can specify up to eight measurement names for both right side and left side calculations. The measurement names also appear in the patient report.

See also “IMT calculations” on page 5-32.

To customize the IMT calculations menu  On the IMT Calculations setup page, do the following: Under IMT Calculations, select measurement names from the lists, or select None. The selected names appear in the calculations menu and in the patient report. Type the desired width in the Region width (mm) box.

Network status setup

The Network Status setup page displays information on system IP address, location, Ethernet MAC address, and the wireless connection if any.

OB calculations setup

On the OB Calculations setup page, you select authors for OB calculation tables. You can also import or export additional OB calculation tables.

See also “OB calculations” on page 5-36.

To specify gestational age and growth analysis 1 On the OB Calculations setup page, select the desired OB authors (or select None) in the measurement lists under Gestational Age and Growth Analysis.

Selecting an author places the associated measurement on the calculations menu. 2 (Optional) Select More to display the list of user-defined custom measurements and to associate a custom table for the custom measurement.

This option is available only when a user-defined custom table has been created for the custom measurement.

3-10 System Setup To export OB calculation tables 1 Insert a USB storage device.

2 On the OB Calculations setup page, select Export. A list of USB devices appears.

3 Select the USB storage device, and select Export.

All user-defined tables and measurements are copied to the USB storage device.

To import OB calculation tables

Tables that you import are added to those already on the system.

1 Insert the USB storage device that contains the tables.

2 On the OB Calculations setup page, select Import on-screen.

3 Select the USB storage device, and then select Import.

4 Select OK in the dialog box that appears.

The system restarts.

OB custom measurements setup

On the OB Custom Measurements setup page, you can define measurements that appear in the OB calculations menu and OB report. OB custom measurements is an optional feature.

See also “OB calculations” on page 5-36.

To set up OB custom measurements

You can save up to five custom measurements that appear in the OB calculations menu and OB report.

1 On the OB Custom Measurements setup page, select New.

2 In the Name box, type a unique name.

3 In the Type list, select the desired measurement type.

4 Select Save.

To delete an OB custom measurement

If you delete an OB custom measurement during an exam, the exam ends.

System Setup 3-11 1 On the OB Custom Measurements setup page, highlight the measurement in the Custom Measurements list.

2 Select Delete Last.

3 Select Yes.

The exam ends, and any tables and report data associated with the measurement are removed from the system.

OB custom tables setup

On the OB Custom Tables setup pages, you can customize growth tables that appear in the calculations menu and patient report.

Gestational Age Table Measurements The system provides gestational age measurements by selected authors for GS, CRL, BPD, OFD, HC, TTD, APTD, AC, FTA, FL, EFW, Tibia, HL, and 5 additional custom measurement labels.

Growth Analysis Table Measurements The system provides growth graphs or curves for BPD, HC, AC, FL, EFW, and HC/AC.

WARNING Prior to use, verify that custom table data entries are correct. The system does not confirm the accuracy of the custom table data entered by the user.

To view OB tables 1 On the OB Calculations or OB Custom Measurements setup page, select Tables on-screen.

2 Select the desired table and measurement/author.

To create a new OB custom table

You can create two custom tables for each OB measurement.

1 On the OB Calculations or OB Custom Measurements setup page, select Tables on-screen.

2 Select the desired table (Gestational Age or Growth Analysis).

3 In the Measurement list, select the measurement for the custom table.

4 Select New on-screen.

5 In the Author box, type a unique name.

3-12 System Setup 6 Enter the data.

7 Select Save on-screen.

To display the measurement for the custom table in the calculations menu, see “To specify gestational age and growth analysis” on page 3-10.

To edit or delete an OB custom table 1 On the OB Calculations or OB Custom Measurements setup page, select Tables on-screen.

2 Select the OB custom table.

3 Select one of the following on-screen:

Edit Enter data, and then select Save on-screen. Delete to remove the custom table. Select Yes.

Presets setup

The Presets setup page has settings for general preferences. You can select from the following lists:

Doppler Scale Select cm/s or kHz.

Duplex The layout for displaying M Mode trace and Doppler spectral trace:1/3 2D, 2/3 Trace; 1/2 2D, 1/2 Trace; or Full 2D, Full Trace.

Live Trace Select Peak or Mean.

Thermal Index You can select TIS, TIB, or TIC. The default setting is based on exam type: OB is TIB, TCD is TIC, and all others are TIS.

Save Key Behavior of the SAVE key. Image Only saves the image to internal storage. Image/Calcs saves the image to internal storage and saves the current calculation to the patient report.

Dynamic Range Settings include -3, -2, -1, 0, +1, +2, or +3. Negative numbers show higher contrast images, and positive numbers show lower contrast images.

Units Units for patient height and weight in cardiac exams: in/ft/lbs or cm/m/kg.

Language The system language. Changing the language requires restarting the system. If you need to change the language selection on the Presets setup page, make sure to first archive, transfer, or export all saved patient data you want to keep. The system may not correctly maintain the saved patient information after the language selection is changed.

System Setup 3-13 Color Scheme The background color of the display.

Auto save Pat. Form Automatically saves the patient information form as an image in the patient’s file.

System information setup

The System Information setup page displays system hardware and software versions, patents, and license information.

To display patents  On the System Information setup page, select Patents.

USB devices setup

On the USB Devices setup page, you can view information about connected USB devices, including space availability. You can also specify a file format for images and clips in patient exams that you export to a USB storage device. (See “Printing, exporting, and deleting images and clips” on page 4-26.)

Specifying a file format for exported images

To specify a file format for exported images 1 On the USB Devices setup page, select Export.

2 Under USB Export, select an export type:

SiteLink organizes files in a SiteLink-style folder structure. Clips export in H.264 video saved as MP4 files. To view them, SonoSite recommends QuickTime 7.0 or later. DICOM creates files readable by a DICOM reader. DICOM is an optional feature. 3 Select an image format for your export type. For JPEG image format, also select a JPEG compression. (See also “Limitations of JPEG format.”)

A high compression has a smaller file size but less detail. For SiteLink export type, the image format affects only still images. For DICOM export type, the image format affects both still images and clips. 4 For SiteLink export type, select a sort order under Sort By.

To return to the previous screen, select Devices.

3-14 System Setup Including private tags

To include private tags

If you use DICOM export type and a SonoSite software product, include private tags on the images.

 On the USB Devices setup page, select Include private tags.

Note Because the tags may be incompatible with some earlier archivers, keep this check box unselected unless you use SonoSite software products. For more information, see M-Turbo System DICOM Conformance Statement.

Limitations of JPEG format

When transferring or exporting images in JPEG format, the system uses lossy compression. Lossy compression may create images that have less absolute detail than BMP format and that don’t render identically to the original images.

In some circumstances, lossy-compressed images may be inappropriate for clinical use. For example, if you use images in SonoCalc® IMT software, you should transfer or export them using BMP format. SonoCalc IMT software uses a sophisticated algorithm to measure images, and lossy compression may cause errors.

For more information on using lossy-compressed images, consult the industry literature, including the following references:

“Physics in Medicine and Biology, Quality Assessment of DSA, Ultrasound and CT Digital Images Compressed with the JPEG Protocol,” D Okkalides et al 1994 Phys Med Biol 39 1407-1421 doi: 10.1088/ 0031-9155/39/9/008 www.iop.org/EJ/abstract/0031-9155/39/9/008 “Canadian Association of Radiologists, CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology,” Approved: June 2008. www.car.ca/Files/%5CLossy_Compression. pdf eFilm Lite image-viewer

You can include a copy of the eFilm Lite image-viewer with exams that you export to a USB memory stick in DICOM format. eFilm Lite lets you view DICOM-formatted images on a computer running Windows. eFilm Lite is a licensed feature.

WARNING Russian characters may appear incorrectly in eFilm Lite. FUJIFILM SonoSite recommends that you do not use the eFilm Lite image-viewer to view exams exported in Russian.

System Setup 3-15 To start eFilm Lite image-viewer after exporting exams 1 Insert the USB memory stick into your computer.

2 Display the USB memory stick’s contents.

3 Double-click eFilmLite.bat.

eFilmLite.bat starts the executable file in the eFilmLite folder. The eFilmLite folder contains the eFilm Lite software and related files. See also the eFilm Lite User’s Guide, a PDF file in the eFilmLite folder.

3-16 System Setup Imaging

Imaging modes

The system has a high-performance display and advanced image-optimization technology that significantly simplifies user controls. Imaging modes available depend on the transducer and exam type. See “Imaging modes and exams available by transducer” on page 4-14.

2D imaging

WARNINGS To avoid incorrect needle placement when MBe is on:

Using movement and fluid injection, verify the needle-tip location and trajectory. MBe enhances linear structures within a selected angle range on the ultrasound plane. Linear structures outside the selected angle range or the ultrasound plane—such as a bent needle—may be less apparent.

Note that linear structures are enhanced only in an outlined portion of the image. The area outside the outline remains unchanged. (See Figure 4-9 on page 4-13.)

Note that the beam divergence of a curved array transducer may prevent a segment of the needle shaft from showing in the image. (See Figure 4-10 on page 4-13.) The needle tip may not show.

2D is the system's default imaging mode. The system displays echoes in two dimensions by assigning a brightness level based on the echo signal amplitude. To achieve the best possible image quality, properly adjust the display brightness, gain, depth settings, viewing angle, and exam type. Also, select an optimization setting that best matches your needs.

To display the 2D image CHAPTER 4 1 Do any of the following:

Turn on the system.

Imaging 4-1 Press the 2D key. 2 Set options as desired.

2D options

In 2D imaging, you can select the following on-screen options.

Table 4-1: 2D options

Control Description Optimize Settings are as follows: Res provides the best possible resolution. Gen provides a balance between resolution and penetration. Pen provides the best possible penetration. Some of the parameters optimized to provide the best image include focal zones, aperture size, frequency (center and bandwidth), and waveform. They cannot be adjusted by the user. Dynamic Adjusts the grayscale range: -3, -2, -1, 0, +1, +2, +3. Range The positive range increases the number of grays displayed, and the negative range decreases the number of grays displayed.

Dual Displays side-by-side 2D images. Select Dual, and then press the UPDATE key to display the second screen and to toggle between the screens. With both images frozen, press the UPDATE key to toggle between the images. To return to full-screen 2D imaging, select Dual or press the 2D key. LVO On, LVO On turns on Left Ventricular Opacification. LVO Off turns off this option. LVO Off Use LVO for cardiac exams in 2D imaging mode when using an imaging contrast agent. LVO lowers the mechanical index (MI) of the system to enhance visualization of the contrast agent and endocardial border. This option depends on transducer and exam type. Orientation Select from four image orientations: U/R (Up/Right), U/L (Up/Left), D/L (Down/Left), D/R (Down/Right).

Brightness Adjusts the display brightness. Settings range from 1 to 10. The display brightness affects battery life. To conserve battery life, adjust brightness to a lower setting.

4-2 Imaging Table 4-1: 2D options

Control Description Guide Turns guidelines on and off. Guidelines are for needle guidance, are an optional feature, and depend on transducer type. For transducers with a single-angle or multi-angle bracket, the touchpad moves the depth cursor. If the transducer uses a multi-angle bracket, select Guide and then select the angle: A, B, or C. To exit angle selection, select Back. To clear the guides, do either of the following: Select the angle again (A, B, or C). Exit angle selection and press Guide. See also the needle guide’s user documentation. Sector (Cardiac exam) Specifies the sector width. SonoMB On is available only for Sector Full.

SonoMB MB On and MB Off turn SonoMB™ multi-beam imaging technology on and off. When (MB) SonoMB is on, MB appears in the upper left-hand screen. SonoMB depends on transducer and exam type.

ECG Displays the ECG trace. See “ECG monitoring” on page 4-27. This feature is optional and requires a FUJIFILM SonoSite ECG cable. Clips Displays the clips options. See “To capture and save a clip” on page 4-22. This feature is optional. THI Turns Tissue Harmonic Imaging on and off. When on, THI appears in the upper left-hand screen. This feature depends on transducer and exam type.

Page x/x Indicates which page of options is displayed. Select to display the next page.

Notes If you use MBe frequently, use a shortcut key to turn on the MBe control. For instructions to program a shortcut key, see “A & B key and footswitch setup” on page 3-1.

Imaging 4-3 2D controls Table 4-2: 2D controls

Control Description MBe Turns on SonoMBe imaging, which enhances linear structures within a selected angle range and can facilitate needle guidance during catheter placement and nerve-block procedures. A three- or four-sided outline indicates the affected area. (See Figure 4-9 on page 4-13.)

Note The MBe control is available in full-screen imaging only with the C60xi transducer.

For curved array transducers, MBe can help identify the direction of the needle, although only segments of the needle shaft may show in the image. (See Figure 4-10 on page 4-13.) Use movement and fluid injection to help verify the needle-tip location. Use a 17-gauge to 25-gauge needle (recommended). Enhancement results can depend on the type and brand of needle used. For more information, consult the medical literature on needle visibility in ultrasound-guided procedures. You can angle the needle up to 50° from the transducer surface. (See Figure 4-8 on page 4-12.) Beyond 50°, the needle may be less enhanced. (MBe has little or no benefit to out-of-plane procedures. MBe is intended for in-plane procedures only.) Avoid setting the gain too high, as unnecessarily high gain can cause artifacts in the image. Also, respiratory and cardiac movement in the image may cause bright pulsating artifacts. When MBe is on, additional controls are available: L/R Flip flips the affected area (the outline) horizontally on the image.

For reorienting the entire image, use the orientation control . Shallow, Medium, or Steep sets the outline’s sloped edge, which is indicated by a dotted line. Linear transducer: Use whichever setting provides best perpendicularity to the dotted line. Within the affected area, the more perpendicular that a linear structure is to the dotted line, the more it is enhanced. Similarly, the less perpendicular (and more parallel) that a linear structure is to the dotted line, the less it is enhanced. Curved array transducer: For a linear structure angled 30° or less from the transducer surface, use Shallow for best enhancement. For a linear structure angled 30-40°, use Medium. For a linear structure angled 40° or greater, use Steep. The current selection is highlighted green. Off turns off MBe. Temporarily turning off MBe can help you identify artifacts and other structures not of interest.

4-4 Imaging Table 4-2: 2D controls

Control Description Back returns to the previous screen. If MBe is on, MBe is highlighted green and MBe appears in the mode data area. Pressing MBe again redisplays the MBe controls. Available in Breast, Musculoskeletal, Nerve, Small Parts, Vascular (L25x only), and Venous (L25x only) exams and in full-screen imaging only. If MBe is on, the MBe control is unavailable.

M Mode imaging

Motion mode (M Mode) is an extension of 2D. It provides a trace of the 2D image displayed over time. A single beam of ultrasound is transmitted, and reflected signals are displayed as dots of varying intensities, which create lines across the screen.

To display the M-line 1 Press the MMODE key.

Note If the M-line does not appear, make sure that the image isn’t frozen.

2 Use the touchpad to position the M-line where desired.

3 Set options as desired.

Many optimization and depth options available in 2D imaging are also available in M Mode imaging. See “2D options” on page 4-2. To display the M Mode trace 1 Display the M-line.

2 Adjust the depth if necessary. (See “To adjust depth” on page 4-10.)

3 Press the MMODE key.

The time scale above the trace has small marks at 200ms intervals and large marks at one-second intervals. 4 Do any of the following as needed:

Select the sweep speed (Slow, Med, or Fast).

Press the UPDATE key to toggle between the M-line and M-Mode trace.

If using a duplex layout, press the MMODE key to toggle between the full-screen M-line and the duplex layout.

Imaging 4-5 To set a duplex layout, see “Presets setup” on page 3-13.

CPD and Color Doppler imaging

Color Power Doppler (CPD) and Color Doppler (Color) are optional features.

CPD is used to visualize the presence of detectable blood flow. Color is used to visualize the presence, velocity, and direction of blood flow in a wide range of flow states.

To display the CPD or Color image 1 Press the COLOR key.

A ROI box appears in the center of the 2D image. 2 Select CPD or Color.

The current selection also appears in the upper left-hand screen. The color indicator bar on the upper left-hand screen displays velocity in cm/s in color imaging mode only.

3 Using the touchpad, position or resize the ROI box as needed. Press the SELECT key to toggle between position and size.

While you position or resize the ROI box, a green outline shows the change. The ROI box indicator on the left-hand screen shows which touchpad function is active. 4 Set options as desired. See “CPD and Color options” on page 4-6.

CPD and Color options

In CPD or color imaging, you can set the following on-screen options.

Table 4-3: CPD and Color options

Control Description Color, CPD Toggle between CPD and Color. The current selection appears in the upper left-hand screen.

Color Shows or hides color information. You can select Show or Hide while in live or Suppress frozen imaging. The setting shown on-screen is the current selection.

4-6 Imaging Table 4-3: CPD and Color options

Flow The current setting appears on-screen. Sensitivity Low optimizes the system for low flow states. Med optimizes the system for medium flow states. High optimizes the system for high flow states. Select the desired pulse repetition frequency (PRF) setting by pressing the control PRF Scale keys. There is a wide range of PRF settings for each Flow Sensitivity setting (Low, Med, and High). Available on select transducers. Wall Filter Settings include Low, Med, and High. Available on select transducers.

Steering Select the steering angle setting of the color ROI box (-15, 0, or +15). If adding PW Doppler, see “PW Doppler options” on page 4-9. Available on select transducers.

Variance Turns variance on and off. Available only for cardiac exam.

Invert Switches the displayed direction of flow. Available in Color imaging.

Sector (Cardiac exam) Specifies the sector width.

Page x/x Indicates which page of options is displayed. Select to display the next page.

PW and CW Doppler imaging

Pulsed wave (PW) Doppler and continuous wave (CW) Doppler imaging modes are optional features.

PW Doppler is a Doppler recording of blood flow velocities in a range specific area along the length of the beam. CW Doppler is a Doppler recording of blood flow velocities along the length of the beam.

You can use PW/CW Doppler and CPD/Color simultaneously. If CPD/Color imaging is on, the color ROI box is tied to the D-line. The SELECT key cycles among color ROI box position; color ROI box size; the D-line and gate location; and (in PW Doppler) angle correction. The active selection is green. Also, the indicator on the left-hand screen shows which touchpad function is active.

Imaging 4-7 To display the D-line

The default Doppler imaging mode is PW Doppler. In cardiac exams, you can select the CW Doppler on-screen option.

1 Press the DOPPLER key.

Note If the D-line does not appear, make sure that the image isn’t frozen.

2 Do any of the following as needed:

Set options. See “PW Doppler options” on page 4-9. Using the touchpad, position the D-line and gate where desired. Horizontal movements position the D-line. Vertical movements position the gate. (PW Doppler) To correct the angle manually, do one of the following:

Press the SELECT key and then use the touchpad. The SELECT key toggles between the D-line and angle correction.

Freeze the image, and then turn the knob. You can adjust the angle in 2° increments from -74° to +74°.

Cardiac imaging applications

You can identify the presence and location of fluid around the heart and lungs, use to assist in pericardiocentesis and thoracentesis procedures, visualize blood flow through cardiac valves, and detect normal lung motion for the presence or absence of pathology.

To display the spectral trace 1 Display the D-line.

2 Press the DOPPLER key.

The time scale above the trace has small marks at 200 ms intervals and large marks at one-second intervals. 3 Do any of the following as needed:

Set options. See “Spectral trace options” on page 4-9.

Press the UPDATE key to toggle between the D-line and spectral trace.

If using a duplex layout, press the DOPPLER key to toggle between the full-screen D-line and the duplex layout. To set a duplex layout, see “Presets setup” on page 3-13.

4-8 Imaging PW Doppler options

In PW Doppler imaging, you can set the following on-screen options.

Table 4-4: PW Doppler options

Control Description PW, CW (Cardiac exam only) Toggle between PW Doppler and CW Doppler. The current selection appears in the upper left-hand screen.

Angle Corrects the angle to 0°, +60°, or -60°. Correction

Gate Size Settings depend on transducer and exam type. In TCD or Orb exams, use the touchpad to specify the Doppler gate depth (the depth of the center of the gate in the Doppler image). The Doppler gate depth indicator is on the lower right-hand screen. TDI On, Select TDI On to turn on tissue Doppler imaging. When on, TDI appears in the upper TDI Off left-hand screen. The default is TDI off. Available only in cardiac exams. Steering Select the desired steering angle setting. Settings available depend on the transducer. The PW Doppler angle correction automatically changes to the optimum setting. -15 and -20 have an angle correction of -60°. 0 has an angle correction of 0°. +15 and +20 have an angle correction of +60°. You can manually correct the angle after selecting a steering angle setting. (See “To display the D-line” on page 4-8.) Available on select transducers. Page x/x Indicates which page of options is displayed. Select to display the next page.

Spectral trace options

In spectral trace imaging, you can set the following on-screen options.

Table 4-5: Spectral trace options

Control Description Scale Select the desired scale (pulse repetition frequency [PRF]) setting. (To change the Doppler scale to cm/s or kHz, see “Presets setup” on page 3-13.

Imaging 4-9 Table 4-5: Spectral trace options

Line Sets the baseline position. (On a frozen trace, the baseline can be adjusted if Live Trace is off.)

Invert Vertically flips the spectral trace. (On a frozen trace, Invert is available if Live Trace is off.)

Volume Increases or decreases Doppler speaker volume (0-10).

Wall Filter Settings include Low, Med, High.

Sweep Settings include Slow, Med, Fast. Speed

Live Trace Displays a live trace of the peak or mean. (See “Presets setup” on page 3-13 to specify peak or mean.)

Page x/x Indicates which page of options is displayed. Select to display the next page.

Adjusting depth and gain

To adjust depth

You can adjust the depth in all imaging modes but the trace modes. The vertical depth scale is marked in 0.5 cm, 1 cm, and 5 cm increments, depending on the depth.

 Press the following keys: UP DEPTH key to decrease the displayed depth.

DOWN DEPTH key to increase the displayed depth. As you adjust the depth, the maximum depth number changes in the lower right screen. To adjust gain automatically  Press the AUTO GAIN key. The gain adjusts each time you press this key.

4-10 Imaging To adjust gain manually  Turn a gain knob:

NEAR adjusts the gain applied to the near field of the 2D image.

FAR adjusts the gain applied to the far field of the 2D image.

GAIN adjusts the overall gain applied to the entire image. In CPD or Color imaging, the GAIN knob affects the color gain applied to the region of interest (ROI) box. In PW and CW Doppler imaging, the GAIN knob affects Doppler gain. Near and far correspond to the time gain compensation (TGC) controls on other ultrasound systems.

Freezing, viewing frames, and zooming

To freeze or unfreeze an image  Press the FREEZE key. On a frozen image, the cine icon and frame number appear in the system status area. To move forward or backward in the cine buffer  Freeze the image, and do one of the following: Turn the knob. Use the touchpad. Right moves forward, and left moves backward.

Press the LEFT ARROW and RIGHT ARROW keys. The frame number changes as you move forward or backward. The total number of frames in the buffer appears on-screen in the system status area. To zoom in on an image

You can zoom in 2D and Color imaging. You can freeze or unfreeze the image or change the imaging mode at any time while zooming.

1 Press the ZOOM key. A ROI box appears.

2 Using the touchpad, position the ROI box as desired.

3 Press the ZOOM key again.

The image in the ROI box is magnified by 100%. 4 (Optional) If the image is frozen, use the touchpad or arrow keys to pan the image up, down, left, and right. (You cannot pan in Dual.)

To exit zoom, press the ZOOM key again.

Imaging 4-11 Needle visualization

About MBe

The MBe control is available in full-screen imaging only and is available on the C60xi transducer.

Transducer Needle

1 0 - 50°

Figure 4-8 Transducer

Notes For best results, angle the needle only up to 50° from the transducer surface.

If you use MBe frequently, use a shortcut key to turn on the MBe control.

For instructions to program a shortcut key, see “A & B key and footswitch setup” on page 3-1.

4-12 Imaging 2 2

1 3

4

Figure 4-9 Image with MBe on (linear transducer)

1 Needle 3 Dotted line 2 Outlined area affected by MBe 4 Unenhanced area

1

2

Figure 4-10 Curved array transducer

1 Upper needle shaft 2 Unshown segment of needle shaft (unshown segment or segments depend on specific image)

Imaging 4-13 Note With a curved array transducer, only segments of the needle shaft might show.

Imaging modes and exams available by transducer

The transducer you use determines which exam types are available. In addition, the exam type you select determines which imaging modes are available.

WARNINGS To prevent misdiagnosis or harm to the patient, understand your system’s capabilities prior to use. The diagnostic capability differs for each transducer, exam type, and imaging mode. In addition, transducers have been developed to specific criteria depending on their physical application. These criteria include biocompatibility requirements.

To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

To change the exam type  Do one of the following: Press the EXAM key, and select from the menu. On the patient information form, select from the Type list under Exam. (See “Patient information form” on page 4-19.). Table 4-6: Imaging modes and exams available by transducer

Imaging mode

Transducer 2D2 PW CW Exam type1 MBe CPD3 Color3 M Mode Doppler4 Doppler C8X Pros  —    — C11x Abd  —    — Neo  —    — Nrv  —    — Vas  —    — C60x Abd  —    — Gyn  —    — Msk      — Nrv      — OB  —    — C60xi Abd —    — 

4-14 Imaging Table 4-6: Imaging modes and exams available by transducer

Imaging mode

Transducer 2D2 PW CW Exam type1 MBe CPD3 Color3 M Mode Doppler4 Doppler Gyn  —    — Msk      — Nrv      — OB  —    — D2x Crd — — — — —  HFL38x Bre      — IMT  —    — Msk      — Nrv      — SmP      — Vas  —    — Ven  —    — HFL50x Bre      — MSK      — Nerve      — SmP      —

Imaging 4-15 Table 4-6: Imaging modes and exams available by transducer

Imaging mode

Transducer 2D2 PW CW Exam type1 MBe CPD3 Color3 M Mode Doppler4 Doppler ICTx Gyn  —    — OB  —    — L25x Msk      — Nrv      — Oph  —    — Sup  —    — Vas      — Ven      — L38x Bre  —    — IMT  —    — Nrv  —    — SmP  —    — Vas  —    — Ven  —    — L38xi Bre  —    — IMT  —    — Msk  —    — Nrv      — SmP  —    — Vas  —    — Ven  —    — P10x Abd  —    — Crd  — —    Neo  —    — P21x Abd  —    — Crd  — —    OB  —    — Orb  —    — TCD  —    — Nrv  —    — Sup  —    — Vas  —    — Ven  —    — SLAx Msk  —    — Nrv  —    —

4-16 Imaging Table 4-6: Imaging modes and exams available by transducer

Imaging mode

Transducer 2D2 PW CW Exam type1 MBe CPD3 Color3 M Mode Doppler4 Doppler Sup  —    — Vas  —    — Ven  —    — TEExi Crd  — —    1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast, Crd = Cardiac, Gyn = Gynecology, IMT = Intima Media Thickness, Msk = Musculoskeletal, Neo = Neonatal, Nrv = Nerve, OB = Obstetrical, Oph = Ophthalmic, Orb = Orbital, SmP = Small Parts, Sup = Superficial, TCD = Transcranial Doppler, Vas = Vascular, Ven = Venous., Pros = Prostate. 2. The optimization settings for 2D are Res, Gen, and Pen. 3. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a range of PRF settings for Color depending on the setting selected. 4. For the cardiac exam type, PW TDI is also available. See “PW Doppler options” on page 4-9.

Annotating images

You can annotate live images as well as frozen images. (You cannot annotate a saved image.) You can place text (including predefined labels), an arrow, or a pictograph. To set preferences for annotations, see “Annotations setup” on page 3-6.

Placing text on an image

To place text on an image

You can place text in the following imaging layouts: full-screen 2D, full-screen trace, dual, or duplex. You can place text manually or add a predefined label.

1 Press the TEXT key. A green cursor appears.

2 Move the cursor where desired:

Use the touchpad or arrow keys. Select Home to move the cursor to the home position. The default home position depends on the imaging screen layout. You can reset the home position. See “To reset the home position” on page 4-18. 3 Using the keyboard, type text.

The arrow keys move the cursor left, right, up, and down.

Imaging 4-17 The DELETE key deletes all text.

The Word option removes a word. Select Symbols to enter special characters. See “Symbols” on page 2-15.

4 (Optional) To add a predefined label, select Label, and then select the desired label group: , , or . Select the group again for the desired label.

The first number shows which label in the group is selected. The second number is the number of labels available. See “Annotations setup” on page 3-6.

To turn off text entry, press the TEXT key.

Resetting the home position

To reset the home position 1 Press the TEXT key.

2 Using the touchpad or arrow keys, position the cursor where desired.

3 Select Home/Set.

Placing an arrow on an image

To place an arrow on an image

You can add an arrow graphic to point out a specific part of the image.

1 Press the ARROW key .

2 If you need to adjust the arrow's orientation, press the SELECT key and then use the touchpad. When the orientation is correct, press the SELECT key again.

3 Using the touchpad, position the arrow where desired.

4 Press the ARROW key to set the arrow.

The arrow changes from green to white.

To remove the arrow, press the ARROW key and then select Hide.

4-18 Imaging Placing a pictograph on an image

To place a pictograph on an image

The pictograph set available depends on transducer and exam type.

1 Press the PICTO key.

2 Select x/x to display the desired pictograph, and then press the SELECT key.

The first number shows which pictograph in the set is selected. The second number is the number of pictographs available. 3 Using the touchpad, position the pictograph marker.

4 (Optional) To rotate the pictograph marker, press the SELECT key and then use the touchpad.

5 Select a screen location for the pictograph: U/L (Up/Left), D/L (Down/Left), D/R (Down/Right), U/R (Up/ Right).

In a duplex layout, the pictograph is restricted to upper left. In Dual, all four positions are available.

To remove the pictograph, select Hide.

Patient information form

The patient information form lets you enter patient identification, exam, and clinical information for the patient exam. This information automatically appears in the patient report.

When you create a new patient information form, all images, clips, and other data you save during the exam are linked to that patient. (See “Patient report” on page 5-45.)

To create a new patient information form 1 Press the PATIENT key.

2 Select New/End.

3 Fill in the form fields. See “Patient information form fields” on page 4-20.

4 Select Done.

See also “Images and clips” on page 4-21.

Imaging 4-19 To edit a patient information form

You can edit patient information if the exam has not been archived or exported and if the information is not from a worklist.

See also “Reviewing patient exams” on page 4-23.

1 Press the PATIENT key.

2 Make changes as desired.

3 Select one of the following:

Cancel to undo changes and return to imaging. Done to save changes and return to imaging. To end the exam 1 Make sure that you have saved images and other data you want to keep. (See “Saving images and clips” on page 4-21.)

2 Press the PATIENT key.

3 Select New/End.

A new patient information form appears.

Patient information form fields

The patient information form fields available depend on exam type. In some fields you can select Symbols to enter symbols and special characters. See “Symbols” on page 2-15.

Patient Last, First, Middle Patient name ID Patient identification number Accession Enter number, if applicable. Date of birth Gender Indications Enter desired text User User initials Procedure (button) Available if the DICOM Worklist feature is licensed and configured. See the DICOM user guide. Select Back to save entries and return to the previous screen.

4-20 Imaging Exam Type Exam types available depend on transducer. See “Imaging modes and exams available by transducer” on page 4-14. LMP Estab. DD (OB or Gyn exam) In an OB exam, select LMP or Estab. DD and then enter either the date of the last menstrual period or the established due date. In a Gyn exam, enter the date of the last menstrual period. The LMP date must precede the current system date. Twins (OB exam) Select the Twins check box to display Twin A and Twin B measurements on the calculations menu and for access to Twin A and Twin B screens for previous exam data. Previous Exams (button) (OB exam) Displays fields for five previous exams. The date for a previous exam must precede the current system date. For twins, select Twin A/B to toggle between Twin A and Twin B screens. (If the Twin A/B option does not appear, select Back, and make sure that the Twins check box is selected.) Select Back to save changes and return to the previous screen. BP (Cardiac, IMT, Orbital, Transcranial, or Vascular exam) Blood Pressure HR (Cardiac, Orbital, Transcranial, or Vascular exam) Heart Rate. Enter the beats per minute. Saving the heart rate using a measurement overwrites this entry. Height (Cardiac exam) The patient height in feet and inches or meters and centimeters. (To change the units, see “Presets setup” on page 3-13.) Weight (Cardiac exam) The patient weight in pounds or kilos. (To change the units, see “Presets setup” on page 3-13.) BSA (Cardiac exam) Body Surface Area. Automatically calculated after you enter height and weight. Ethnicity (IMT exam) Ethnic origin Reading Dr. Referring Dr. Institution

Images and clips

Saving images and clips

When you save an image or clip, it saves to internal storage. The system beeps afterward if Beep Alert is on, and the percentage icon flashes. (See “Audio and battery setup” on page 3-8.) The percentage icon in the system status area shows the percentage of space used in internal storage. If you try to save an image or clip when no space remains, the system alerts you that internal storage is full. To resolve this issue, archive images and clips that you wish to keep, and then delete them from the system to free up space. To receive alerts when storage is near capacity, see “To receive storage alerts” on page 3-9. The percentage icon in the system status area shows the percentage of space available in internal storage.

To access saved images and clips, open the patient list. See “Reviewing patient exams” on page 4-23.

Imaging 4-21 To save an image  Press the SAVE key. The image saves to internal storage.

By default, the SAVE key saves only the image. As a shortcut during calculations, the SAVE key can save both the image to internal storage and the calculation to the patient report. See “Presets setup” on page 3-13.

To capture and save a clip

Clips, an optional feature, lets you capture, preview, and save clips.

1 Set Clips options. (See “To set clips options” on page 4-23.)

2 Press the CLIP key.

One of the following occurs: If Prev/Off is selected, the clip saves directly to internal storage. If Prev/On is selected, the clip plays back in preview mode. You can select any of the following on-screen:

A playback speed (1x, 1/2x, 1/4x)

Pause to interrupt playback

Left: x or Right: x to remove frames from the left or right sides of the clip (where x is the beginning or ending frame number)

Save to save the clip to internal storage

Delete to delete the clip

4-22 Imaging To set clips options

Setting clips options ensures that clips are captured to your specifications.

1 In 2D imaging mode, select Clips on-screen.

2 Set options as desired.

Table 4-7: Clips options

Control Description

Time, ECG Time and ECG share the same location on-screen. With Time, capturing is based on number of seconds. Select the time duration. With ECG, capturing is based on the number of heart beats. Select the number of beats. Preview On, PrevOn and PrevOff turn the preview feature on and off. Preview Off With Prev/On, the captured clip automatically plays on-screen. The clip can be trimmed, saved, or deleted. With Prev/Off, the clip saves to internal storage, and the trim and delete options are not available. Prospective, Pro and Retro determine how clips are captured: Retrospective With Pro, a clip is captured prospectively, after you press the CLIP key. With Retro, a clip is captured retrospectively, from pre-saved data before you press the CLIP key.

Reviewing patient exams

Caution If the internal storage icon does not appear in the system status area, internal storage may be defective. Contact FUJIFILM SonoSite technical support. (See “Getting help” on page 1-3.)

The patient list organizes saved images and clips in patient exams. You can delete, view, print, or archive exams. You can also copy them to a USB storage device.

Imaging 4-23 Figure 4-11 Patient List

To display the patient list 1 Press the REVIEW key.

2 If there is an active exam, select List on-screen.

To sort the patient list

After the system starts, the patient list is arranged by date and time, with the most recent patient file first. You can re-sort the patient list as needed.

 Select the column heading that you want to sort by. Select it again if sorting in reverse order.

Note The column heading is selectable.

To select patients in the patient list  Using the touchpad, select the check box for one or more patients. Select All selects all patients.

To deselect patients, select checked boxes or Clear All.

To edit patient information from the patient list

You can edit the patient name and ID from the patient list instead of from the patient information form if the exam has ended but has not been exported or archived.

1 In the patient list, select the patient.

2 Select Edit.

4-24 Imaging 3 Fill in the form fields, and select OK.

To append images and clips to a patient exam

Although you cannot add images and clips to a patient exam that has ended, you can automatically start a new patient exam that has the same patient information. Depending on your archiver, the two exams appear as one study when exported or archived.

1 Select the exam in the patient list.

2 Select Append on-screen.

A new patient information form appears. The form has the same information as the exam you selected. To review images and clips

You can review images and clips in only one patient exam at a time.

1 In the patient list, highlight the patient exam whose images and clips you want to review.

2 Select Review on-screen.

3 Select x/x to cycle to the image or clip you want to review.

4 (Clip Only) Select Play.

The clip plays automatically after loading. The load time depends on clip length.

You can select Pause to freeze the clip and can select a playback speed 1x, 1/2x, 1/4x.

5 Select x/x to cycle to the next image or clip you want to view.

To return to the patient list, select List. To return to imaging, select Done.

Imaging 4-25 Printing, exporting, and deleting images and clips

WARNINGS To avoid damaging the USB storage device and losing patient data from it, observe the following: Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break.

To print an image 1 Verify that a printer is selected. See “To configure the system for a printer” on page 3-8.

2 Do one of the following:

In the patient list, review the patient’s images. Select Print when the image appears.

With the image displayed, press the A shortcut key.

By default, the A shortcut key prints. To reprogram the A and B shortcut keys, see “Presets setup” on page 3-13. To print multiple images 1 Verify that a printer is selected. See “To configure the system for a printer” on page 3-8.

2 Do one of the following:

Print all images for multiple patients: Select one or more patients in the patient list. Then select Print. Print all images for one patient: Highlight the patient in the patient list, and then select Print. Each image appears briefly on-screen while printing. To export patient exams to a USB storage device

You can export patient exams if they are ended. (See “To end the exam” on page 4-20.)

A USB storage device is for temporary storage of images and clips. Patient exams should be archived regularly. To specify file format, see “USB devices setup” on page 3-14.

1 Insert the USB storage device.

2 In the patient list, select the patient exams you want to export.

3 Select Exp. USB on-screen. A list of USB devices appears.

4-26 Imaging 4 Select the USB storage device. If you want to hide patient information, deselect Include patient information on images and clips.

Only available USB devices are selectable. 5 Select Export.

The files are finished exporting approximately five seconds after the USB animation stops. Removing the USB storage device or turning off the system while exporting may cause exported files to be corrupted or incomplete. To stop in-progress exporting, select Cancel Export. To delete images and clips 1 Select one or more patients in the patient list.

2 Select Delete to delete the selected patients. A confirmation screen appears.

To manually archive images and clips

You can send patient exams to a DICOM printer or archiver, or to a PC using SiteLink Image Manager. DICOM and SiteLink Image Manager are optional features. For more information about archiving, see the DICOM and SiteLink Image Manager documentation.

1 Select one or more patients in the patient list.

2 Select Archive.

To display information about a patient exam 1 On the patient list, select the exam.

2 Select Info.

ECG monitoring

ECG monitoring is an optional feature and requires a FUJIFILM SonoSite ECG cable.

WARNINGS To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms. The FUJIFILM SonoSite ECG option is a non-diagnostic feature.

To avoid electrical interference with aircraft systems, do not use the ECG cable on aircraft. Such interference may have safety consequences.

Caution Use only accessories recommended by FUJIFILM SonoSite with the system. Your system can be damaged by connecting an accessory not recommended by FUJIFILM SonoSite.

Imaging 4-27 If you defibrillate a patient while the ECG module is connected to the system, the ECG signal may display incorrectly, and the ECG module may need to be replaced.

Note Biopsy guidelines are not available when ECG is connected. The ECG signal may take up to one minute to restabilize after defibrillator use on the patient.

The ECG signal may take up to one minute to restabilize after defibrillator use on a patient.

To monitor ECG 1 Connect the ECG cable to the ECG connector on the ultrasound system, mini-dock, or docking system.

ECG monitoring turns on automatically.

Note An external ECG monitor may cause a lag in the timing of the ECG trace, corresponding with the 2D image. Biopsy guidelines are not available when ECG is connected.

2 Select ECG on-screen. (ECG may be on another page. It appears only if the ECG cable is connected.)

3 Select options as desired.m

Table 4-8: ECG monitoring options

Show/ Turns on and off ECG trace. Hide

Gain Increases or decreases ECG gain. Settings are 0-20.

Position Sets the position of the ECG trace.

Sweep Settings are Slow, Med, and Fast. Speed

Displays Line and Save for clip acquisition delay. (For instructions to capture clips, Delay see “To capture and save a clip” on page 4-22.)

4-28 Imaging Table 4-8: ECG monitoring options

Line The position of the delay line on the ECG trace. The delay line indicates where the clip acquisition is triggered.

Saves the current position of the delay line on the ECG trace. (You can change the position of the delay line temporarily. Starting a new patient information form or Save cycling system power reverts the delay line to the most recently saved position.) Select Delay to display these options.

Imaging 4-29 4-30 Imaging Measurements and Calculations

You can measure for quick reference, or you can measure within a calculation. You can perform general calculations as well as calculations specific to an exam type.

Measurements are performed on frozen images. For references used, see Chapter 6, “References.”

Measurements

You can perform basic measurements in any imaging mode and can save the image with the measurements displayed. (See “Saving images and clips” on page 4-21.) Except for the M Mode HR measurement, the results do not automatically save to a calculation and the patient report. If you prefer, you can first begin a calculation and then measure. See “Performing and saving measurements in calculations” on page 5-9.

Some options may not apply to your system. Options available depend on your configuration, transducer, and exam type.

To save a measurement to a calculation and patient report 1 With the measurement active (green), press the CALCS key.

2 From the calculations menu, select a measurement name.

Only measurement names available for the imaging mode and exam type are selectable. 3 Save the calculation. (See “To save a calculation” on page 5-9.)

To start a calculation before measuring, see “Performing and saving measurements in calculations” on page 5-9. CHAPTER 5

Measurements and Calculations 5-1 Working with calipers

When measuring, you work with calipers, often in pairs. Results based on the calipers’ position appear at the bottom of the screen. The results update as you reposition the calipers by using the touchpad. In trace measurements, the results appear after you complete the trace.

Outside a calculation, you can add calipers by pressing the CALIPER key. You can have multiple sets of calipers and can switch from one set to another, repositioning them as needed. Each set shows the measurement result. The active calipers and measurement result are highlighted green. A measurement is complete when you finish moving its calipers.

Within a calculation, calipers appear when you select from the calculations menu. (See “To select from the calculations menu” on page 5-8.)

For an accurate measurement, accurate placement of calipers is essential.

To switch the active calipers  Do one of the following: To switch the active caliper within a set, press the SELECT key. To switch the active set when measuring outside a calculation, select Switch on-screen. To delete or edit a measurement  With the measurement active (highlighted), do one of the following: To delete, select Delete on-screen. To edit, use the touchpad to move the calipers.

Note Trace measurements cannot be edited once set.

To improve precision of caliper placement  Do any of the following: Adjust the display for maximum sharpness. Use leading edges (closest to the transducer) or borders for starting and stopping points. Maintain a consistent transducer orientation for each type of measurement. Make sure that the area of interest fills as much of the screen as possible. (2D) Minimize the depth, or zoom.

2D measurements

The basic measurements that you can perform in 2D imaging are as follows:

Distance in cm

5-2 Measurements and Calculations Area in cm2 Circumference in cm

You can also measure area or circumference by tracing manually.

Figure 5-1 2D image with two distance and one circumference measurement

You can perform a combination of distance, area, circumference, and manual trace measurements at one time. The total number possible depends on their order and type.

To measure distance (2D)

You can perform up to eight distance measurements on a 2D image.

1 On a frozen 2D image, press the CALIPER key.

A pair of calipers appears, connected by a dotted line.

2 Using the touchpad, position the first caliper, and then press the SELECT key.

The other caliper becomes active. 3 Using the touchpad, position the other caliper.

If you move the calipers close together, they shrink and the dotted line disappears.

See “To save a measurement to a calculation and patient report” on page 5-1.

To measure area or circumference (2D) 1 On a frozen 2D image, press the CALIPER key.

Measurements and Calculations 5-3 2 Select Ellipse on-screen.

Note If you exceed the allowed number of measurements, Ellipse is not available.

3 Use the touchpad to adjust the size and position of the ellipse. The SELECT key toggles between position and size.

See “To save a measurement to a calculation and patient report” on page 5-1.

To trace manually (2D) 1 On a frozen 2D image, press the CALIPER key.

2 Select Manual on-screen.

Note If you exceed the allowed number of measurements, Manual is not available.

3 Using the touchpad, position the caliper where you want to begin.

4 Press the SELECT key.

5 Using the touchpad, complete the trace, and press the SET key.

See “To save a measurement to a calculation and patient report” on page 5-1.

M Mode measurements

The basic measurements that you can perform in M Mode imaging are as follows:

Distance in cm/Time in seconds Heart Rate (HR) in beats per minute (bpm)

The time scale above the trace has small marks at 200 ms intervals and large marks at one-second intervals.

To measure distance (M Mode)

You can perform up to four distance measurements on an image.

1 On a frozen M Mode trace, press the CALIPER key.

A single caliper appears. 2 Using the touchpad, position the caliper.

3 Press the SELECT key to display the second caliper.

5-4 Measurements and Calculations 4 Using the touchpad, position the second caliper.

See “To save a measurement to a calculation and patient report” on page 5-1.

To measure heart rate (M Mode) 1 On a frozen M Mode trace, press the CALIPER key.

2 Select HR on-screen.

A vertical caliper appears. 3 Using the touchpad, position the vertical caliper at the peak of the heartbeat.

4 Press the SELECT key.

A second vertical caliper appears. 5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.

See “To save a measurement to a calculation and patient report” on page 5-1. Saving the heart rate measurement to the patient report overwrites any heart rate entered on the patient information form.

See also “To measure fetal heart rate (M Mode)” on page 5-39.

Doppler measurements

The basic measurements that you can perform in Doppler imaging are Velocity (cm/s), Pressure Gradient, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration. You can also trace manually or automatically.

For Doppler measurements, the Doppler scale must be set to cm/s. See “Presets setup” on page 3-13.

To measure velocity (cm/s) and pressure gradient (Doppler) 1 On a frozen Doppler spectral trace, press the CALIPER key.

A single caliper appears. 2 Using the touchpad, position the caliper to a peak velocity waveform.

This measurement involves a single caliper from the baseline.

See “To save a measurement to a calculation and patient report” on page 5-1.

Measurements and Calculations 5-5 To measure velocities, elapsed time, +/x ratio, resistive index (RI), and acceleration (Doppler) 1 On a frozen Doppler spectral trace, press the CALIPER key.

A single caliper appears. 2 Using the touchpad, position the caliper to a peak systolic waveform.

3 Press the SELECT key.

A second caliper appears. 4 Using the touchpad, position the second caliper at the end diastole on the waveform.

See “To save a measurement to a calculation and patient report” on page 5-1.

To measure time duration (Doppler) 1 On a Doppler spectral trace, press the CALIPER key.

2 Press Time on-screen.

A vertical caliper appears.

3 Using the touchpad, position the caliper where desired, and press the SELECT key.

A second caliper appears.

4 Using the touchpad, position the second caliper where desired, and press the SELECT key.

To trace manually (Doppler) 1 On a frozen Doppler spectral trace, press the CALIPER key.

2 Select Manual on-screen.

A single caliper appears.

3 Using the touchpad, position the caliper at the beginning of the desired waveform, and press the SELECT key.

If calipers are not positioned correctly, the result is inaccurate. 4 Using the touchpad, trace the waveform.

To make a correction, select Undo on-screen, backtrack with the touchpad, or press the BACKSPACE key.

5 Press the SET key.

The measurement results appear.

5-6 Measurements and Calculations See “To save a measurement to a calculation and patient report” on page 5-1.

To trace automatically (Doppler)

After tracing automatically, confirm that the system-generated boundary is correct. If you are not satisfied with the trace, obtain a high-quality Doppler spectral trace image, or trace manually. (See “To trace manually (Doppler)” on page 5-6.)

1 On a frozen Doppler spectral trace, press the CALIPER key.

2 Select Auto on-screen.

A vertical caliper appears. 3 Using the touchpad, position the caliper at the beginning of the waveform.

If calipers are not positioned correctly, the calculation result is inaccurate.

4 Press the SELECT key.

A second vertical caliper appears. 5 Using the touchpad, position the second caliper at the end of the waveform.

6 Press the SET key.

The measurement results appear.

See “To save a measurement to a calculation and patient report” on page 5-1.

Automatic trace results

Depending on the exam type, the results from automatic tracing include the following:

Velocity time integral (VTI) Peak velocity (Vmax) Mean pressure gradient (PGmean) Mean velocity on peak trace (Vmean) Pressure gradient (PGmax) Cardiac output (CO) Peak systolic velocity (PSV) Time average mean (TAM)* +/× or systolic/diastolic (S/D) Pulsatility index (PI) End diastolic velocity (EDV) Acceleration time (AT) Resistive index (RI)

Measurements and Calculations 5-7 Time average peak (TAP) Gate depth

General calculations

Within calculations, you can save measurement results to the patient report. You can display, repeat, and delete measurements from a calculation. Some measurements can be deleted directly from the patient report pages. See “Patient report” on page 5-45.

Calculation packages depend on exam type and transducer.

Unexpected data loss

Patient exam calculations on ultrasound workflows can be lost without warning or indication if certain settings change prior to ending any current (open) studies. See the following caution:

Caution Changes made to any of the following settings will cause analysis values in the current (open) study to be cleared. These settings should not be changed before ending any open study on the system. Date and time OB tables or custom measurements Cardiac TDI labels IMT labels Doppler units

Calculations menu

The calculations menu contains measurements available for the imaging mode and exam type. After you perform and save a measurement, the result saves to the patient report. (See “Patient report” on page 5-45.) Also, a check mark appears next to the measurement name in the calculations menu. If you highlight the checked measurement name, the results appear below the menu. If you repeat the measurement, the results below the menu reflect either the last measurement or the average, depending on the measurement.

Menu items followed by ellipses (. . .) have sub-entries.

To select from the calculations menu 1 On a frozen image, press the CALCS key.

The calculations menu appears.

5-8 Measurements and Calculations 2 Using the touchpad or arrow keys, highlight the desired measurement name.

To display additional measurement names, highlight Next, Prev, or a measurement name that has ellipses (. . .). Then press the SELECT key. Only measurement names available for the imaging mode are selectable.

3 Press the SELECT key.

To close the calculations menu, press the CALCS key once (if the menu is active) or twice (if the menu is inactive).

Performing and saving measurements in calculations

In performing a measurement within a calculation, you select from the calculations menu, position the calipers that appear, and then save the calculation. Unlike measurements performed outside a calculation, the calipers appear by selecting from the calculations menu, not by pressing the CALIPER key. The type of calipers that appear depends on the measurement.

To save a calculation  Do one of the following: Save the calculation only: Press the SAVE CALC key, or select Save on-screen. The calculation saves to the patient report. To save the image with the measurements displayed, see “To save an image” on page 4-22.

Save both the image and calculation: Press the SAVE key if the SAVE key functionality is set to Image/ Calcs. (See “Presets setup” on page 3-13.) The calculation saves to the patient report, and the image saves to internal storage with the measurements displayed.

Displaying, repeating, and deleting saved measurements in calculations

To display a saved measurement  Do one of the following: Highlight the measurement name in the calculations menu. The result appears below the menu. Open the patient report. See “Patient report” on page 5-45. To repeat a saved measurement 1 Highlight the measurement name in the calculations menu.

2 Press the SELECT key or the CALIPER key.

Measurements and Calculations 5-9 3 Perform the measurement again.

The new results appear on-screen in the measurement and calculations data area. (See “Screen layout” on page 2-11.) You can compare them to the saved results below the menu.

4 To save the new measurement, press the SAVE CALC key.

The new measurement saves to the patient report and overwrites the previously saved measurement. To delete a saved measurement 1 Select the measurement name from the calculations menu.

2 Select Delete on-screen.

The measurement last saved is deleted from the patient report. If it is the only measurement, the check mark is deleted from the calculations menu.

Some measurements can be deleted directly from the patient report pages. See “Patient report” on page 5-45.

EMED calculations

The results from EMED calculations automatically appear in the EMED worksheets. All EMED calculations are available for each exam type.

To perform an EMED calculation: 1 Press the CALCS key.

2 Select EMED on-screen.

The calculations menu becomes the EMED calculations menu. 3 Select the calculation name.

4 Perform a distance measurement.

5 Save the measurement.

To return to the calculations menu, select Calcs on-screen.

5-10 Measurements and Calculations Percent reduction calculations

WARNING To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared.

Table 5-1: Transducers and exam types

Transducer Exam types

C11x Abdomen, Vascular

C60x Abdomen, Msk

C60xi Abdomen, Msk

HFL38x IMT, Small Parts, Vascular

HFL50x Msk, Small Parts

L25x Msk, Vascular

L38x IMT, Small Parts, Vascular

L38xi IMT, Msk, Small Parts, Vascular

P10x Abdomen

P21x Abdomen

SLAx Msk, Vascular

Measurements and Calculations 5-11 Figure 5-2 Percent area reduction calculation of right carotid bulb

To calculate percent area reduction

The percent area reduction calculation involves two manual trace measurements.

1 On a frozen 2D image, press the CALCS key.

2 Do the following for A1 and then for A2:

a From the calculations menu, select the measurement name under Area Red.

b Using the touchpad, move the caliper to the trace starting point, and press the SELECT key. c Using the touchpad, trace the desired area.

To make a correction, select Undo on-screen or press the BACKSPACE key.

d Complete the trace, and press the SET key. e Save the calculation. See “To save a calculation” on page 5-9. The percent area reduction result appears on-screen in the measurement and calculation data area and in the patient report. To calculate percent diameter reduction 1 On a frozen 2D image, press the CALCS key.

2 Do the following for D1 and then for D2:

a From the calculations menu, select the measurement name under Dia Red. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. See “To save a calculation” on page 5-9.

5-12 Measurements and Calculations The percent diameter reduction result appears in the measurement and calculation data area and in the patient report.

Volume calculations

WARNINGS To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared.

Table 5-2: Transducers and exam types

Transducer Exam types C8x Prostate C11x Abdomen, Neonatal, Nerve, Vascular, C60x Abdomen, Gyn, Msk, Nerve C60xi Abdomen, Gyn, Msk, Nerve HFL38x Breast, Nerve, Small Parts, Vascular HFL50x Breast, Msk, Nerve, Small Parts ICTx Gyn L25x Msk, Nerve, Superficial, Vascular L38x Breast, Nerve, Small Parts, Vascular L38xi Breast, Msk, Nerve, Small Parts, Vascular P10x Abdomen, Neonatal P21x Abdomen SLAx Msk, Nerve, Superficial, Vascular

Note When performing volume flow measurements, the factor identified in the literature that affects the accuracy is difficulty ensuring uniform insonation of the vessel. The system is limited to the following sample volume sizes: C60xi transducer: 2, 3, 5, 7, 10, 12 Gate Size (mm).

To calculate volume

The volume calculation involves three 2D distance measurements: D1, D2, and D3. After all measurements are saved, the result appears on-screen and in the patient report.

 Do the following for each image you need to measure:

Measurements and Calculations 5-13 a On the frozen 2D image, press the calcs key. b Do the following for each measurement you need to take: i From the calculations menu, select the measurement name under Volume. (If Volume is not available in a Gyn exam, select Gyn and then select Volume.) ii Position the calipers. (See “Working with calipers” on page 5-2.) iii Save the measurement. See “To save a calculation” on page 5-9. Volume flow calculations Table 5-3: Transducers and exam types

Transducer Exam types C11x Abdomen, Vascular C60x Abdomen C60xi Abdomen HFL38x Vascular L25x Vascular L38x Vascular L38xi Vascular P10x Abdomen P21x Abdomen SLAx Vascular

WARNINGS To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 4-19.

The following table shows the measurements required to complete the volume flow calculation. For definitions of acronyms, see “Glossary” on page A-1.

Table 5-4: Volume flow calculations

Measurement Menu heading Calculation result (Imaging mode) Vol Flow D (2D)* VF (Volume Flow ml/min) TAM or TAP (Doppler) * Required if measuring the diameter instead of using the gate size

5-14 Measurements and Calculations Both a 2D and a Doppler measurement are required for the volume flow calculation. For the 2D measurement, you can do either of the following:

Measure the diameter of the vessel. This approach is more precise. The measurement overrides the gate size. Use the gate size. If you do not measure the diameter of the vessel, the system automatically uses the gate size and “(gate)” appears in the calculation results.

The Doppler sample volume should completely insonate the vessel. You can measure either the time average mean or time average peak. To specify the live trace setting, see “Presets setup” on page 3-13.

Consider the following factors when performing volume flow measurements:

Users should follow current medical practice for volume flow calculation applications. The accuracy of the volume flow calculation largely depends on the user. The factors identified in the literature that affect the accuracy are as follows: Using the diameter method for 2D area Difficulty ensuring uniform insonation of the vessel. The system is limited to the following sample volume sizes: C11x transducer: 1, 2, 3 Gate Size (mm)

C60x and P10x transducers: 2, 3, 5, 7, 10, 12 Gate Size (mm)

C60xi transducer: 2, 3, 5, 7, 10, 12 Gate Size (mm)

HFL38x, L25x, and SLAx transducers: 1, 3, 5, 6, 7, 8, 10, 12 Gate Size (mm)

P21x transducer: 2, 3, 5, 7, 11.5, 14 Gate Size (mm)

Precision in placing the caliper Accuracy in angle correction

The considerations and degree of accuracy for volume flow measurements and calculations are discussed in the following references:

Allan, Paul L. et al. Clinical Doppler Ultrasound, 4th Ed., Harcourt Publishers Limited, (2000) 36-38. To calculate volume flow 1 If measuring the diameter instead of using the gate size, perform the 2D measurement:

a On a frozen full-screen 2D image or duplex image, press the CALCS key. b From the calculations menu, select D (distance) under Vol Flow. c Position the calipers. (See “Working with calipers” on page 5-2.)

Measurements and Calculations 5-15 d Save the calculation. See “To save a calculation” on page 5-9. 2 Perform the Doppler measurement:

a On a frozen Doppler spectral trace, press the CALCS key. b From the calculations menu, select TAM or TAP under Vol Flow. A vertical caliper appears. c Using the touchpad, position the vertical caliper at the beginning of the waveform. If calipers are not positioned correctly, the calculation result is inaccurate.

d Press the SELECT key to display a second vertical caliper. e Using the touchpad, position the second vertical caliper at the end of the waveform.

f Press the SET key to complete the trace and to display the results. g Save the calculation. See “To save a calculation” on page 5-9.

Results appear at the bottom of the screen as well as save to the patient report.

Exam-based calculations

In addition to the general calculations, there are calculations specific to the Cardiac, Gynecology (Gyn), IMT, OB, Orbital, Small Parts, Transcranial Doppler (TCD), and Vascular exam types.

Cardiac calculations Table 5-5: Transducers and exam types

Transducer Exam type D2x Cardiac P10x Cardiac P21x Cardiac TEEx Cardiac TEExi Cardiac

WARNINGS To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

5-16 Measurements and Calculations To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 4-19.

The following table shows the measurements required to complete different cardiac calculations. For definitions of acronyms, see “Glossary” on page A-1.

Table 5-6: Cardiac calculations

Menu heading Cardiac measurements (Imaging mode) Calculation results LV…LVd RVW (2D) CO RVD (2D) EF IVS (2D) SV LVD (2D) LVESV LVPW (2D) LVEDV …LVs RVW (2D) IVSFT RVD (2D) LVPWFT IVS (2D) LVDFS LVD (2D) CI LVPW (2D) SI HRa needed for CO & CI Ao/LA Ao (2D or M Mode) Ao LA/Ao AAo (2D) AAo LA (2D or M Mode) LA LA/Ao LVOT D (2D) LVOT D LVOT area ACS (M Mode) ACS LVET (M Mode) LVET MV EF: Slope (M Mode) EF SLOPE EPSS (M Mode) EPSS

Measurements and Calculations 5-17 Table 5-6: Cardiac calculations

Menu heading Cardiac measurements (Imaging mode) Calculation results LV…LVd RVW (M Mode) CO RVD (M Mode) EF IVS (M Mode) SV LVD (M Mode) LVESV LVPW (M Mode) LVEDV …LVs RVW (M Mode) IVSFT RVD (M Mode) LVPWFT IVS (M Mode) LVDFS LVD (M Mode) CI LVPW (M Mode) SI LV Mass HR HRa Area AV (2D) AV Area MV (2D) MV Area LV Vol (EF) A4Cd (2D) LV Vol A4Cs (2D) LV Area A2Cd (2D) EF A2Cs (2D) CO SV CI SI Biplane LV mass Epi (2D) LV Mass Endo (2D) Epi Area Apical (2D) Endo Area D Apical PISA Ann D (2D) PISA Area Radius (Color) ERO MR/VTI (Doppler) MV Rate MV/VTI (Doppler) Regurgitant Volume Regurgitant Fraction Qp/Qs LVOT D (2D) D RVOT D (2D) VTI LVOT VTI (Doppler) VMax RVOT VTI (Doppler) PGmax Vmean PGmean SV Qp/Qs

5-18 Measurements and Calculations Table 5-6: Cardiac calculations

Menu heading Cardiac measurements (Imaging mode) Calculation results CO LVOT D (2D) — (Doppler) CO SV CI SI VTI HR LVOT D TDI (Wall) e’ and a (Doppler) E(MV)/e’ ratio (Wall) e’ and a (Doppler) (Wall) e’ and a (Doppler) (Wall) e’ and a (Doppler) (Wall) e’ and a (Doppler)

Measurements and Calculations 5-19 Table 5-6: Cardiac calculations

Menu heading Cardiac measurements (Imaging mode) Calculation results P. Ve in A (Doppler) VMax Adur (Doppler) time S (Doppler) VMax D (Doppler) S/D ratio MV E (Doppler) E A (Doppler) E PG A A PG E:A Adur (Doppler) time PHT (Doppler) PHT MVA Decel time VTI (Doppler) VTI Vmax PGmax Vmean PGmean IVRT (Doppler) time MV…MR dP:dTb (CW Doppler) dP:dT AV Vmax (Doppler) Vmax PGmax VTI (Doppler) VTI Vmax PGmax Vmean PGmean VTI or Vmax from LVOT (Doppler) AVA VTI or Vmax from AV (Doppler) Ao/LA LVOT D (2D) AV VTI (Doppler) SV Ao/LA LVOT D (2D) AV VTI (Doppler) CO Ao/LA LVOT D (2D) HR HRa

5-20 Measurements and Calculations Table 5-6: Cardiac calculations

Menu heading Cardiac measurements (Imaging mode) Calculation results LVOT Vmax (Doppler) Vmax PGmax VTI (Doppler) VTI Vmax PGmax Vmean PGmean AV…AI PHT (slope) (Doppler) AI PHT AI slope TV TRmax (Doppler) Vmax PGmax E (Doppler) E A (Doppler) E PG A A PG E:A PHT (Doppler) PHT MVA Decel time VTI (Doppler) VTI Vmax PGmax Vmean PGmean RA pressurec RVSP PV Vmax (Doppler) Vmax PGmax VTI (Doppler) VTI AT (Doppler) Vmax PGmax Vmean PGmean AT a. You can enter the HR measurement three ways: Patient information form, Doppler measurement (See “To calculate heart rate (HR)” on page 5-28), or M Mode measurement (See “To measure heart rate (M Mode)” on page 5-5). b. Performed at 100 cm/s and 300 cm/s. c. Specified on the cardiac patient report. See “To delete a vascular or cardiac measurement” on page 5-46.

Measurements and Calculations 5-21 To measure LVd and LVs 1 On a frozen 2D image or M Mode trace, press the CALCS key.

2 From the calculations menu, select the measurement name.

3 Position the active (green) caliper at the starting point. (See “Working with calipers” on page 5-2.)

4 Press the SELECT key, and position the second caliper.

5 Press the SELECT key.

Another caliper appears, and the calculations menu highlights the next measurement name.

6 Position the caliper, and press the SELECT key. Repeat for each measurement name in the calculation group.

Each time you press the SELECT key, another caliper appears, and the calculations menu highlights the next measurement name. 7 Save the calculation. (See “To save a calculation” on page 5-9.)

To measure Ao, LA, AAo, or LVOT D 1 On a frozen 2D image or M Mode trace, press the CALCS key.

2 From the calculations menu, select the measurement name.

3 Position the calipers. (See “Working with calipers” on page 5-2.)

4 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate LV Volume (Simpson’s Rule) 1 On a frozen 2D image, press the CALCS key.

2 Do the following for each measurement:

a From the calculations menu, select the desired view and phase.

b Position the caliper at the mitral annulus, and press the SELECT key to start the trace. c Using the touchpad, trace the left ventricular (LV) cavity.

To make a correction, select Undo on-screen or press the BACKSPACE key.

d Complete the trace, and press the SET key. e Save the calculation. (See “To save a calculation” on page 5-9.) To calculate MV or AV area 1 On a frozen 2D image, press the CALCS key.

5-22 Measurements and Calculations 2 In the calculations menu, locate Area, and then select MV or AV.

3 Position the caliper where you want to begin the trace, and press the SELECT key.

4 Using the touchpad, trace the desired area.

To make a correction, select Undo on-screen or press the BACKSPACE key.

5 Complete the trace, and press the SET key.

6 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate LV Mass 1 On a frozen 2D image, press the CALCS key.

2 In the calculations menu, locate LV Mass.

3 Do the following for EPI and then for Endo:

a Select the measurement name from the calculations menu.

b Position the caliper where you want to begin the trace, and press the SELECT key. c Using the touchpad, trace the desired area.

To make a correction, select Undo on-screen or press the BACKSPACE key.

d Complete the trace, and press the SET key. e Save the calculation. (See “To save a calculation” on page 5-9.). 4 Select Apical from the calculations menu.

5 Positioning the calipers, measure the ventricular length. (See “Working with calipers” on page 5-2.)

6 Save the calculation.

To measure peak velocity

For each cardiac measurement, the system saves up to five individual measurements and calculates their average. If you take more than five measurements, the most recent measurement replaces the fifth one. If you delete a saved measurement from the patient report, the next measurement taken replaces the deleted one in the patient report. The most recently saved measurement appears at the bottom of the calculations menu.

1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select MV, TV, TDI, or P. Ve i n .

Measurements and Calculations 5-23 3 Do the following for each measurement you want to take:

a Select the measurement name from the calculations menu. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.) To calculate velocity time integral (VTI)

Note This calculation computes other results in addition to VTI. See the table “Cardiac calculations” on page 5-16.

1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select VTI under MV, AV, TV, PV, or LVOT.

3 Position the caliper at the start of the waveform, and press the SELECT key to start the trace.

4 Using the touchpad, trace the waveform.

To make a correction, select Undo on-screen, backtrack with the touchpad, or press the BACKSPACE key.

5 Press the SET key to complete the trace.

6 Save the calculation. (See “To save a calculation” on page 5-9.)

For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 5-7.

To calculate Right Ventricular Systolic Pressure (RVSP) 1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select TV and then select TRmax.

3 Position the caliper. (See “Working with calipers” on page 5-2.)

4 Save the calculation. (See “To save a calculation” on page 5-9.)

5 To adjust the RA pressure, see “To delete a vascular or cardiac measurement” on page 5-46.

Changing the RA pressure from the default 5 affects the RVSP calculation in the patient report. To calculate pressure half time (PHT) in MV, AI, or TV 1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select MV, AV, or TV, and then select PHT.

5-24 Measurements and Calculations 3 Position the first caliper at the peak, and press the SELECT key.

A second caliper appears. 4 Position the second caliper:

In MV, position the caliper along the EF slope. In AV, position the caliper at the end diastole. 5 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate proximal isovelocity surface area (PISA)

The PISA calculation requires a measurement in 2D, a measurement in Color, and two measurements in Doppler spectral trace. After all measurements are saved, the result appears in the patient report.

1 Measure from Ann D (2D):

a On a frozen 2D image, press the CALCS key. b From the calculations menu, locate PISA, and then select Ann D. c Position the calipers. (See “Working with calipers” on page 5-2.) d Save the calculation. (See “To save a calculation” on page 5-9.) 2 Measure from radius (Color):

a On a frozen color image, press the CALCS key. b From the calculations menu, select Radius. c Position the calipers. d Save the calculation.

3 On a frozen Doppler spectral trace, press the CALCS key.

4 Do the following to measure from MR VTI and again to measure from MV VTI (Doppler):

a From the calculations menu, select PISA and then select MR VTI or MV VTI.

b Position the caliper at the start of the waveform, and press the SELECT key to start the trace. c Using the touchpad, trace the waveform.

To make a correction, select Undo on-screen, backtrack with the touchpad, or press the BACKSPACE key.

d Press the SET key to complete the trace. e Save the calculation.

For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 5-7.

Measurements and Calculations 5-25 To calculate Isovolumic Relaxation Time (IVRT) 1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select MV and then select IVRT.

A vertical caliper appears. 3 Using the touchpad, position the caliper at the aortic valve closure.

4 Press the SELECT key.

A second vertical caliper appears. 5 Using the touchpad, position the second caliper at onset of mitral inflow.

6 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate delta pressure: delta time (dP:dT)

To perform the dP:dT measurements, the CW Doppler scale must include velocities of 300 cm/s or greater on the negative side of the baseline. (See “Spectral trace options” on page 3-32.)

1 On a frozen CW Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select MV, and then select dP:dT.

A horizontal dotted line with an active caliper appears at 100 cm/s. 3 Position the first caliper along the waveform at 100 cm/s.

4 Press the SELECT key.

A second horizontal dotted line with an active caliper appears at 300 cm/s. 5 Position the second caliper along the waveform at 300 cm/s.

6 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate aortic valve area (AVA)

The AVA calculation requires a measurement in 2D and two measurements in Doppler. After the measurements are saved, the result appears in the patient report.

1 In 2D, measure from LVOT:

a On a frozen 2D image, press the calcs key. b From the Calculations menu, select AV then LVOT D.

5-26 Measurements and Calculations c Position the calipers. d Save the calculation. 2 In Doppler, select AV, measure LVOT, and then measure the AV.

To calculate Qp/Qs

The Qp/Qs calculation requires two measurements in 2D and two measurements in Doppler. After the measurements are saved, the result appears in the patient report.

1 On a frozen 2D image, press the CALCS key.

2 Do the following to measure from LVOT D and again to measure from RVOT D:

a From the calculations menu, locate Qp/Qs and then select LVOT D or RVOT D. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.)

3 On a frozen Doppler spectral trace, press the CALCS key.

4 Do the following to measure from LVOT VTI and again to measure from RVOT VTI:

a From the calculations menu, select Qp/Qs and then select LVOT VTI or RVOT VTI.

b Press the SELECT key to start the trace. c Using the touchpad, trace the waveform.

To make a correction, select Undo on-screen, backtrack with the touchpad, or press the BACKSPACE key.

d Press the SET key to complete the trace. e Save the calculation. (See “To save a calculation” on page 5-9.)

For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 5-7.

To calculate stroke volume (SV) or stroke index (SI)

The SV and SI calculations require a measurement in 2D and a measurement in Doppler. SI also requires body surface area (BSA). After the measurements are saved, the result appears in the patient report.

1 Fill in the Height and Weight fields on the patient information form. The BSA is calculated automatically. (SI only.)

2 Measure from LVOT (2D).

a On a frozen 2D image, press the calcs key. b From the 2D main menu, select AO/LA.

Measurements and Calculations 5-27 c From the Calculations menu, select LVOT D. d Position the calipers. e Save the calculation. 3 Measure from LVOT (Doppler).

a On a frozen Doppler image, press the calcs key. b From the Calculations menu, select AV, and then select LVOT VTI. c Position the calipers. d Save the calculation.

For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 5-7.

To calculate heart rate (HR)

Heart rate is available in all cardiac packages. The heart rate is not calculated using the ECG trace.

Saving the heart rate to the patient report overwrites any heart rate entered on the patient information form.

1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select HR.

A vertical caliper appears. 3 Using the touchpad, position the first vertical caliper at the peak of the heartbeat.

4 Press the SELECT key.

A second vertical caliper appears. The active caliper is highlighted green. 5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.

6 Save the calculation. (See “To save a calculation” on page 5-9.)

To calculate cardiac output (CO) or cardiac index (CI)

The CO and CI calculations require stroke volume and heart rate calculations. CI also requires body surface area (BSA). After the measurements are saved, the result appears in the patient report.

1 (CI Only) Fill in the Height and Weight fields on the patient information form. The BSA is calculated automatically. (See “To create a new patient information form” on page 4-19.)

2 Calculate SV. See “To calculate stroke volume (SV) or stroke index (SI)” on page 5-27.

5-28 Measurements and Calculations 3 Calculate HR. See “To calculate heart rate (HR)” on page 5-28.

To calculate cardiac output automatically

WARNINGS To avoid incorrect calculation results, make sure that the Doppler signal does not alias.

To avoid an incorrect diagnosis: Do not use automatic cardiac output calculations as the sole diagnostic criteria. Use them only in conjunction with other clinical information and patient history. Do not use automatic cardiac output calculations in neonatal patients. To avoid inaccurate velocity measurements if you use PW Doppler, make sure that angle correction is set to zero.

The system can maintain the accuracy of automatic cardiac output measurements only if the flow rate is 1 L/min or greater.

1 Measure from LVOT (2D):

a On a frozen 2D image, press the CALCS key. b From the calculations menu, select CO, and then select LVOT D. c Position the calipers. (See “Working with calipers” on page 5-2.) d Save the calculation. (See “To save a calculation” on page 5-9.) 2 Trace automatically (Doppler):

The automatic trace tool always measures the peak regardless of the Live Trace setting in Presets setup. a Display the Doppler spectral trace (waveform). b Select Trace on-screen, and then select Above or Below for the position of the automatic trace tool relative to the baseline. The automatic trace tool appears in yellow. The results appear at the bottom of the screen. c Freeze the image.

If you want to change the waveform measured, move each vertical caliper by pressing SELECT and then using the touchpad. Press SET to update the results. If you invert the frozen image or move the baseline, results are cleared. If you want to hide the results, select Trace. d Save the calculation.

Measurements and Calculations 5-29 To measure a tissue Doppler imaging (TDI) waveform 1 Ensure that TDI is on. (See “PW Doppler options” on page 4-9.)

2 On a frozen Doppler spectral trace, press the CALCS key.

3 From the calculations menu, select TDI, and then do the following for each measurement you want to take:

a From the calculations menu, select the measurement name. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.)

Measurement publications and terminology (cardiac)

The following are additional references for the cardiac exam type.

Left Ventricular Mass in gm for 2D

Schiller, N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantification of the Left Ventricle by Two-Dimensional Echocardiography.” Journal of American Society of Echocardiography. September-October 1998, 2:364.

LV Mass = 1.05 * {[(5/6) * A1 * (a + d + t)] - [(5/6) * A2 * (a + d)]} where: A1 = Short axis area, diastole (Epi) A2 = Short axis area, diastole (Endo) a = Long or semi major axis d = Truncated semi major axis from the widest short axis diameter to mitral annulus plane t = Myocardial thickness

Left Ventricular Mass in gm for M Mode

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1999), 39.

LV Mass = 1.04 [(LVID + PWT + IVST)3 – LVID3] * 0.8 + 0.6

where: LVID = Internal Dimension PWT = Posterior Wall Thickness IVST = Interventricular Septal Thickness 1.04 = Specific gravity of the myocardium 0.8 = Correction factor

5-30 Measurements and Calculations Gynecology (Gyn) calculations

Gynecology (Gyn) calculations include Uterus, Ovary, Follicle, and Volume. For instructions to calculate volume, see “Volume calculations” on page 5-13.

WARNINGS To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 4-19.

Table 5-7: Transducers and exam types

Transducer Exam type

C60x Gyn

C60xi Gyn

ICTx Gyn

To measure uterus or ovary 1 On a frozen 2D image, press the CALCS key.

2 From the calculations menu, select Gyn.

3 Do the following for each measurement you want to take:

a Select the measurement name from the calculations menu. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.) To measure follicles

On each side, you can save up to three distance measurements on a follicle, for up to 10 follicles.

If you measure a follicle twice, the average appears in the report. If you measure a follicle three times, the average and a volume calculation appear in the report.

1 On a frozen 2D image, press the CALCS key.

Measurements and Calculations 5-31 2 From the calculations menu, select Follicle.

3 Do the following for each measurement you want to take:

a From the calculations menu, select the follicle number under Right Fol or Left Fol. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.)

IMT calculations

Table 5-8: Transducers and exam types

Transducer Exam type

L38x IMT

L38xi IMT

HFL38x IMT

WARNINGS To ensure high quality images, all patient images must be obtained by qualified and trained individuals.

To avoid patient injury, IMT results should not be used as a sole diagnostic tool. All IMT results should be interpreted in conjunction with other clinical information or risk factors.

To avoid measurement errors, all measurements must be of the common carotid artery (CCA). This tool is not intended for measuring the bulb or the internal carotid artery (ICA).

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 4-19.

5-32 Measurements and Calculations The following table shows available measurements for IMT calculations. The IMT measurement names are specified on the IMT setup page. See “IMT calculations setup” on page 3-10.

Table 5-9: IMT calculations (2D)

Menu heading Available measurements Right-IMT Ant N (Anterior Near Wall) Left-IMT Ant F (Anterior Far Wall) Lat N (Lateral Near Wall) Lat F (Lateral Far Wall) Post N (Posterior Near Wall) Post F (Posterior Far Wall) IMT 1 IMT 2 IMT 3 IMT 4 IMT 5 IMT 6 IMT 7 IMT 8 Plaque Plaq 1 Plaq 2

To calculate IMT automatically 1 On a frozen 2D image, press the CALCS key.

2 From the calculations menu, select the measurement.

3 Using the touchpad or arrow keys, position the IMT tool over the area of interest until the measurement results appear.

4 Adjust the tool, and edit as needed. See “IMT tool options” on page 5-33.

5 Save the calculation. (See “To save a calculation” on page 5-9.)

IMT tool options

When using the IMT tool, you can select the following options on-screen.

Table 5-10: Options

Option Description Hide Use to check results. Hides the measurement results and trace line. Select Show to redisplay them.

Measurements and Calculations 5-33 Table 5-10: Options

Option Description Move Repositions the tool horizontally by several pixels. The upper key moves the tool right, and the lower key moves the tool left.

Width Adjusts the tool width by 1 mm. The upper key increases the width, and the lower key decreases the width.

Edit Displays Smooth, Adven, and Lumen. Adjusts the IMT line smoothing. Smooth Select Edit to display this option. Adven Adjusts the adventitia-media line. The upper key moves the line upward. The lower key moves the line downward. Select Edit to display this option.

Lumen Adjusts the lumen-intima line. The upper key moves the line upward. The lower key moves the line downward. Each of the two IMT lines can be adjusted independently. Select Edit to display this option. To trace IMT manually

In manually tracing IMT, the user defines the location.

1 On a frozen 2D image, press the CALCS key

2 From the calculations menu, select a measurement name.

3 Select Edit on-screen, and then select Manual, and then select Sketch.

A single caliper appears, and Trace appears next to the measurement. 4 Do the following for the desired adventitia-media boundary and then for the lumen-intima boundary:

a Position the caliper at the beginning of the boundary, and press the SELECT key. b Using the touchpad, mark points by moving the caliper to the next desired point and pressing the SELECT key.

To make a correction, select Undo on-screen or press the BACKSPACE key to delete the last segment.

c Press the SET key to complete the trace line. 5 Save the calculation. (See “To save a calculation” on page 5-9.)

5-34 Measurements and Calculations To sketch IMT

The IMT sketch measurement involves two user-defined sketch lines that you can adjust manually.

1 On a frozen 2D image, press the CALCS key.

2 From the calculations menu, select a measurement name.

3 Select Edit on-screen, and then select Manual.

A single caliper appears on-screen, and Sketch appears next to the measurement. 4 Do the following for the desired adventitia-media boundary and then for the lumen-intima boundary:

a Position the caliper at the beginning of the boundary and press the SELECT key. b Using the touchpad, mark points by moving the caliper to the next desired point and pressing the SELECT key.

To make a correction, select Undo on-screen or press the BACKSPACE key to delete the last segment.

c Press the SET key to complete the trace line. d If necessary, adjust or edit the measurement. See “IMT tool options” on page 5-33. e Save the calculation. (See “To save a calculation” on page 5-9.)

Measurements and Calculations 5-35 OB calculations

WARNINGS Make sure that you have selected the OB exam type and the OB author for the OB calculation table you intend to use. See “Results from system-defined OB measurements and table authors” on page 5-37.

To avoid incorrect obstetrics calculations, verify with a local clock and calendar that the system’s date and time settings are correct before each use of the system. The system does not automatically adjust for daylight savings time changes.

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 4-19.

Prior to use, verify that OB custom table data entries are correct. The system does not confirm the accuracy of the custom table data entered by the user.

EFW is calculated only after appropriate measurements are completed. If any one of these parameters results in an EDD greater than what the OB calculation tables provide, the EFW is not displayed.

Table 5-11: Transducers and exam types

Transducer Exam type C60x OB C60xi OB ICTx OB P21x OB

If you change the calculation author during the exam, the common measurements are retained.

The following table shows the system-defined measurements available for OB calculations by author. For definition of the acronyms, see “Glossary” on page A-1. To select authors, see “OB calculations setup” on page 3-10.

See also “OB custom measurements setup” on page 3-11 and “OB custom tables setup” on page 3-12.

5-36 Measurements and Calculations Results from system-defined OB measurements and table authors

Gestational OB Calculation result Table authors measurements Gestational Agea YS — GS Hansmann, Nyberg, Tokyo U. CRL Hadlock, Hansmann, Osaka, Tokyo U. BPD Chitty, Hadlock, Hansmann, Osaka, Tokyo U. OFD Hansmann HC Chitty, Hadlock, Hansmann TTD Hansmann, Tokyo U.b APTD Tokyo U.b AC Hadlock, Hansmann, Tokyo U. FTA Osaka FL Chitty, Hadlock, Hansmann, Osaka, Tokyo U. HL Jeanty Tibia Jeanty TCD — CM — Lat V — CxLen — Estimated Fetal Weight HC, AC, FL Hadlock 1 (EFW)c BPD, AC, FL Hadlock 2 AC, FL Hadlock 3 BPD, TTD Hansmann BPD, FTA, FL Osaka U. BPD, AC Shepard BPD, TTD, APTD, FL Tokyo U. Ratios HC/AC Campbell FL/AC Hadlock FL/BPD Hohler FL/HC Hadlock Amniotic Fluid Index Q1, Q2, Q3, Q4 Jeng

Measurements and Calculations 5-37 Results from system-defined OB measurements and table authors

Gestational OB Calculation result Table authors measurements Growth Analysis Tablesd BPD Chitty, Hadlock, Jeanty HC Chitty, Hadlock, Jeanty AC Chitty, Hadlock, Jeanty FL Chitty, Hadlock, Jeanty EFW Brenner, Hadlock, Jeanty HC/AC Campbell a. The gestational age is automatically calculated and displayed next to the OB measurement you selected. The average of the results is the AUA. b. For Tokyo U., APTD and TTD are used only to calculate EFW. No age or growth tables are associated with these measurements. c. The estimated fetal weight calculation uses an equation that consists of one or more fetal biometry measurements. The author for the OB tables, which you choose on a system setup page, determines the measurements you must perform to obtain an EFW calculation. (See “OB Calculations setup” on page 2-20.) Individual selections for Hadlock’s EFW equations 1, 2, and 3 are not determined by the user. The selected equation is determined by the measurements that have been saved to the patient report with priority given to the order listed above. d. The growth analysis tables are used by the report graphs feature. Three growth curves are drawn using the table data for the selected growth parameter and published author. Growth tables are only available with a user-entered LMP or Estab. DD. To measure gestational growth (2D)

For each 2D OB measurement (except AFI), the system saves up to three individual measurements and their average. If you take more than three measurements, the earliest measurement is deleted.

1 In the patient information form, select OB exam type, and select LMP or Estab.DD. Select Twins if appropriate.

2 On a frozen 2D image, press the CALCS key.

3 Do the following for each measurement you want to take:

a From the calculations menu, select the measurement name. For twins, select Twin A or Twin B, and then select the measurement name. The caliper tool may change depending on the measurement selected, but the position remains constant. b Position the calipers. (See “Working with calipers” on page 5-2.) c Save the calculation. (See “To save a calculation” on page 5-9.)

5-38 Measurements and Calculations To measure fetal heart rate (M Mode) 1 On a frozen M Mode trace, press the CALCS key.

2 Select FHR from the calculations menu.

A vertical caliper appears. 3 Using the touchpad, position the vertical caliper at the peak of the heartbeat.

4 Press the SELECT key.

A second vertical caliper appears. 5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.

6 Save the calculation. (See “To save a calculation” on page 5-9“To save a calculation” on page 5-9

Table 5-12: OB Doppler calculations

Menu heading OB calculation Results MCA (Middle Cerebral Artery) S/D, RI SD RI S/D, RI, PI* SD RI PI Umb A (Umbilical Artery) S/D, RI SD RI S/D, RI, PI* SD RI PI *Calculation requires a trace measurement.

To calculate MCA or Umba (Doppler)

Note The system does not provide an MCA/UmbA ratio from the PI (pulsatility index).

1 Select OB exam type, and select LMP or Estab.DD in the patient information form.

2 On a frozen Doppler spectral trace, press the CALCS key.

3 Do the following for each measurement you need to take:

a From the calculations menu, select the measurement name under MCA (middle cerebral artery) or UmbA (umbilical artery). b Position the calipers:

Measurements and Calculations 5-39 For S/D, RI, position the first caliper at the peak systolic waveform. Press the SELECT key, and position the second caliper at the end diastole on the waveform.

For S/D, RI, PI, position the caliper at the beginning of the desired waveform, and press the SELECT key. Use the touchpad to manually trace the desired area. Press the SET key. If calipers are not positioned correctly, the calculation result is inaccurate.

c Save the calculation. (See “To save a calculation” on page 5-9.) Only one calculation (S/D, RI or S/D, RI, PI) can be saved.

Small parts calculations

Small parts calculations include volume, hip angle, and d:D ratio. For instructions to calculate volume, see “Volume calculations” on page 5-13.

Table 5-13: Transducers and exam types

Transducer Exam type HFL38x Small Parts HFL50x Small Parts L38x Small Parts L38xi Small Parts

To calculate hip angle 1 On a frozen 2D image, press the CALCS key.

2 From the calculations menu, select Right or Left.

3 Select Baseline under Hip Angle.

A baseline appears on-screen.

4 Position the baseline, and press the SET key. (See “Working with calipers” on page 5-2.)

Line A (alpha line) appears on-screen, and Line A is selected in the calculations menu. 5 Position Line A, and save the measurement. (See “To save a calculation” on page 5-9.)

Line B (beta line) appears on-screen, and Line B is selected in the calculations menu. 6 Position Line B, and save the measurement.

To calculate d:D ratio 1 On a frozen 2D image, press the CALCS key.

5-40 Measurements and Calculations 2 From the calculations menu, select Right or Left.

3 Under d:D Ratio, select Fem Hd (femoral head).

4 Using the touchpad, position and resize the circle. The SELECT key toggles between position and size.

5 Press the SET key.

The baseline automatically appears with the left caliper active. 6 Position the caliper. (See “Working with calipers” on page 5-2.)

7 Save the measurement. (See “To save a calculation” on page 5-9.)

Transcranial Doppler and orbital calculations Table 5-14: Transducer and exam type

Transducer Exam types P21x Transcranial (TCD), Orbital (Orb)

WARNINGS To avoid injury to the patient, use only an orbital (Orb) exam type when performing imaging through the eye.

Verify that the patient information, date, and time settings are accurate.

To avoid carrying over measurements from the previous patient, start a new patient information form for each new patient before you perform calculations on the new patient. See “To create a new patient information form” on page 4-19.

Measurements and Calculations 5-41 The following table shows the measurements required to complete transcranial Doppler (TCD) and orbital (Orb) calculations. For definitions of acronyms, see “Glossary” on page A-1.

Table 5-15: Transcranial and orbital calculations

TCD and Orb Menu heading Results measurements TT TAP MCA Dist PSV Mid EDV Prox PI RI Bifur* S/D ACA Gate size ACoA* TICA

TT PCAp1 PCAp2 PCoA TO OA TAP Siphon PSV EDV PI RI S/D Gate Size SM ECICA TAP PSV EDV PI RI S/D Gate Size FM VA TAP FM PSV BA Prox EDV Mid PI Dist RI S/D Gate size

5-42 Measurements and Calculations Table 5-15: Transcranial and orbital calculations AL ECVA TAP PSV EDV PI RI S/D Gate size *Available but not required

WARNING To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orbital or Ophthalmic exam type is selected.

To perform a transcranial Doppler or orbital calculation 1 Select the correct exam type:

Orbital (Orb) to measure opthalmic artery and siphon

Transcranial (TCD) for other measurements

See “To change the exam type” on page 4-14.

2 On a frozen Doppler spectral trace, press the CALCS key.

3 From the calculations menu, select Left or Right.

4 Do the following for each measurement you want to take:

a From the calculations menu, select the measurement. (You may need to select Next or Prev to locate the measurement.) b Do one of the following:

For a manual trace measurement, use the touchpad to position the caliper. Press the SELECT key. Use the touchpad to trace the waveform.

If you need to make a correction, select Undo on-screen or press the BACKSPACE key. For an auto trace measurement, select Auto on-screen, and use the touchpad to position the first caliper at the beginning of the waveform. Press the SELECT key, and position the second caliper at the end of the waveform. Confirm that the system-generated boundary is correct. If you are not satisfied with the trace, obtain a higher quality Doppler spectral trace image, or trace manually.

Measurements and Calculations 5-43 c Press the SET key. d Save the calculation. (See “To save a calculation” on page 5-9.)

Vascular calculations Table 5-16: Transducers and exam types

Transducer Exam type C11x Vascular HFL38x Vascular L25x Vascular L38x Vascular L38xi Vascular SLAx Vascular

WARNINGS To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations. Starting a new patient information form clears the previous patient’s data. The previous patient’s data will be combined with the current patient if the form is not first cleared. See “To create a new patient information form” on page 3-40.

To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate.

The vascular measurements that you can save to the patient report are listed in the following table. For definitions of acronyms, see “Glossary” on page A-1.

Table 5-17: Vascular calculations

Menu heading Vascular measurement Calculation results CCA Prox s (systolic), d (diastolic) Mid s (systolic), d (diastolic) Dist s (systolic), d (diastolic) Bulb s (systolic), d (diastolic) ICA Prox s (systolic), d (diastolic) Mid s (systolic), d (diastolic) Dist s (systolic), d (diastolic) ECA Prox s (systolic), d (diastolic) Mid s (systolic), d (diastolic) Dist s (systolic), d (diastolic) VArty s (systolic), d (diastolic)

5-44 Measurements and Calculations To perform a vascular calculation

After you perform vascular measurements, values in the ICA/CCA ratios are selectable on the vascular page of the patient report.

1 On a frozen Doppler spectral trace, press the CALCS key.

2 From the calculations menu, select Left or Right.

3 Do the following for each measurement you want to take:

a From the calculations menu, select the measurement name. b Using the touchpad, position the caliper at the peak systolic waveform.

c Press the SELECT key. A second caliper appears. d Using the touchpad, position the second caliper at the end diastole on the waveform. e Save the calculation. (See “To save a calculation” on page 5-9.) Table 5-18: Exam types and calculations for L38xi transducer

Exam type Calculations Bre Volume IMT IMT Percent Reduction Msk Percent Reduction Volume Nrv Volume SmP Percent Reduction Small Parts Volume Vas Percent Reduction Vascular Volume Volume Flow

Patient report

The patient report contains calculation results and patient information. For Cardiac, OB, Transcranial, and Vascular exams, the patient report has additional details and features.

You can display the patient report at any time during the exam.

Measurements and Calculations 5-45 The value for a calculation appears only if the calculation is performed. The pound symbol (###) indicates a value that is out of range (for example, too large or small). Calculation values that are out of range are not included in derived calculations (for example, mean).

If you transfer or export an exam from the ultrasound system, the following measurements do not appear in the exported patient report. If you need to record them, save the report as an image (press the SAVE key) before transferring or exporting, or write them manually into the patient record.

GYN exam: Follicle Cardiac exam: Automatically calculated CO values (CO, SV, CI, SI, VTI, Vmax, Vmean, PGmax, PGmean, LVOT D, LVOT area) To display a patient report 1 Press the REPORT key.

2 Do any of the following:

To display additional pages, select 1/x on-screen. (Cardiac, Vascular, or TCD) Select Details or Summary on-screen. The mean of the detail entries is used in the summary.

3 (Optional) Press the SAVE key to save the current page of the patient report.

To exit the patient report and return to imaging, select Done.

To send a patient report to a PC

You can send a patient report to a PC as a text file.

1 Ensure correct configuration. See “To configure the system for a DVD recorder, PC, or serial bar code scanner” on page 3-9.

Make sure to use the connection cable supplied by FUJIFILM SonoSite. Other connection cables may cause audio interference, including an inaudible Doppler signal. 2 Select Send Rep. on-screen.

Vascular and cardiac patient reports

To delete a vascular or cardiac measurement 1 On the Details page of the patient report, select the measurement by using the touchpad. (The selected measurement is green.)

5-46 Measurements and Calculations 2 Select Delete on-screen.

Deleting some measurements also deletes related measurements. Deleted measurements are not included in the summary information. (Vascular) To modify the ICA/CCA ratio  In the Ratio list in the vascular patient report, select measurements for the ICA/CCA ratio for both the right and left sides. (Cardiac) To adjust the RA pressure  On the Summary page of the cardiac patient report, select from the RA list.

Changing the RA pressure from the default 5 affects the RVSP calculation result.

TCD patient report

The maximum values for the TAP calculation appear on the summary page.

To delete a row of TCD measurements 1 On the Details page of the TCD patient report, select the row’s TAP measurement using the touchpad. (The selected measurement is green.)

2 Select Delete on-screen.

Deleted measurements are not included in the summary information.

OB patient report

The OB patient report pages have a space for signing printed reports.

To display the OB Twins patient report  On the OB patient report, select one of the following on-screen: Twin A/B for individual twin patient reports

Compare for both twins in one patient report

To delete an OB measurement 1 On the OB patient report, select the OB measurement by using the touchpad.

The selected measurement is green.

Measurements and Calculations 5-47 2 Select Delete on-screen.

To delete all measurements, select the measurement label and press the SELECT key and then select Delete on-screen. To fill out the OB anatomy checklist

You can document reviewed anatomy.

 On the Anatomy Checklist page in the OB patient report, select the check boxes. Press the TAB key to move between fields and the SPACEBAR to select and deselect items in the checklist. To complete the OB biophysical profile  On page 2 of the OB patient report, select values under BPP. The total is calculated when values are selected. NST (non-stress test) is optional. To display OB graphs

You can display OB graphs if the LMP or Estab. DD fields are complete in the patient information form.

1 On the OB patient report, select Graphs on-screen.

2 In the Graphs list, select the desired measurement/author.

The graph for the selected measurement appears. You can select another measurement/author or select 1/x on-screen. For twins, both measurement sets are plotted on the same graph.

3 (Optional) Press the SAVE key to save the current graph page.

4 Select one of the following on-screen:

Report to return to the previous patient report page

Done to return to live imaging.

EMED worksheets

EMED worksheets contain results from EMED calculations and checklists that you can complete.

To display an EMED worksheet

This feature is optional.

1 After or during the exam, press the REPORT key.

5-48 Measurements and Calculations 2 Select EMED on-screen.

3 Select the worksheet from the Worksheet list or by selecting x/x on-screen.

MSK worksheets

MSK worksheets have lists from which you can select and a field for entering comments.

To display an MSK worksheet

This feature is optional.

1 After or during the exam, press the REPORT key.

2 Select MSK on-screen.

3 Select the worksheet from the Worksheet list.

To display additional pages in the worksheet, select x/x on-screen. Each worksheet has its own comments field, which remains on-screen even if you display another page in the worksheet.

If you want to save a worksheet page, press the SAVE key.

Measurements and Calculations 5-49 5-50 Measurements and Calculations References

Measurement accuracy

The measurements provided by the system do not define a specific physiological or anatomical parameter. Rather, the measurements are of a physical property such as distance for evaluation by the clinician. The accuracy values require that you can place the calipers over one pixel. The values do not include acoustic anomalies of the body.

The 2D linear distance measurement results are displayed in centimeters with one place past the decimal point, if the measurement is ten or greater; two places past the decimal point, if the measurement is less than ten.

The linear distance measurement components have the accuracy and range shown in the following tables.

Table 6-19: 2D Measurement accuracy and range

2D Measure System Accuracy accuracy b Range (cm) a by Test method and range tolerance Axial distance < ±2% plus 1% of full Acquisition Phantom 0-26 cm scale Lateral distance < ±2% plus 1% of full Acquisition Phantom 0-35 cm scale Diagonal distance < ±2% plus 1% of full Acquisition Phantom 0-44 cm scale Areac < ±4% plus (2% of Acquisition Phantom 0.01-720 cm full scale/smallest dimension) * 100 plus 0.5% Circumferenced < ±3% plus (1.4% of Acquisition Phantom 0.01-96 cm full scale/ smallest dimension) * 100 CHAPTER 6 plus 0.5%

References 6-1 Table 6-19: 2D Measurement accuracy and range (continued)

2D Measure System Accuracy accuracy b Range (cm) a by Test method and range tolerance aFull scale for distance implies the maximum depth of the image. bAn RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. cThe area accuracy is defined using the following equation: % tolerance = ((1 + lateral error) * (1 + axial error) – 1) * 100 + 0.5%. dThe circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following equation: % tolerance = (2 (maximum of 2 errors) * 100) + 0.5%.

Table 6-20: M Mode measurement and calculation accuracy and range

MMode measurement System Accuracy by Test method Range accuracy and tolerance range

Distance < +/- 2% Acquisition Phantomb 0-26 cm plus 1% of full scalea

Time < +/- 2% Acquisition Phantomd 0.01-10 sec plus 1% of full scalec

Heart Rate < +/- 2% Acquisition Phantomd 5-923 bpm plus (Full Scalec * Heart Rate/ 100) %

aFull scale for distance implies the maximum depth of the image. bAn RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. cFull scale for time implies the total time displayed on the scrolling graphic image. dFUJIFILM SonoSite special test equipment was used.

6-2 References Table 6-21: PW Doppler mode measurement and calculation accuracy and range

Doppler mode measurement System Test Accuracy by Range accuracy and tolerance methoda range

Velocity cursor < +/- 2% plus 1% Acquisition Phantom 0.01 cm/sec- of full scaleb 550 cm/sec

Frequency cursor < +/- 2% plus 1% Acquisition Phantom 0.01kHz-20.8 of full scaleb kHz

Time < +/- 2% plus 1% Acquisition Phantom 0.01-10 sec of full scalec

aFUJIFILM SonoSite special test equipment was used. bFull scale for frequency or velocity implies the total frequency or velocity magnitude, displayed on the scrolling graphic image. cFull scale for time implies the total time displayed on the scrolling graphic image.

Sources of measurement errors

In general, two types of errors can be introduced into the measurement:

Acquisition error Includes errors introduced by the ultrasound system electronics relating to signal acquisition, signal conversion, and signal processing for display. Additionally, computational and display errors are introduced by the generation of the pixel scale factor, application of that factor to the caliper positions on the screen, and the measurement display. Algorithmic error The error introduced by measurements, which are input to higher order calculations. This error is associated with floating-point versus integer-type math, which is subject to errors introduced by rounding versus truncating results for display of a given level of significant digit in the calculation.

Measurement publications and terminology

The following sections list the publications and terminology used for each calculation result.

Terminology and measurements comply with AIUM published standards.

References 6-3 Cardiac references

Acceleration (ACC) in cm/s2

Zwiebel, W.J. Introduction to Vascular Ultrasonography. 4th ed., W.B. Saunders Company, (2000), 52.

ACC = abs (delta velocity/delta time)

Acceleration time (AT) in msec

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 219.

Aortic valve area (AVA) by continuity equation in cm2

Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition., Philadelphia: Lippincott, Williams, and Wilkins, (2007), p.73, 191-195.

A2 = A1 * V1/V2 where: A2 = Ao valve area A1 = LVOT area (CSA) V1 = LVOT velocity (VMax) V2 = Ao valve velocity (VMax) LVOT = Left Ventricular Outflow Tract

Body Surface Area (BSA) in m2

Grossman, W. Cardiac Catheterization and Angiography. Philadelphia: Lea and Febiger, (1980), 90.

BSA = 0.007184 * Weight0.425 * Height0.725

Weight = kilograms

Height = centimeters

Cardiac Index (CI) in l/min/m2

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1999), 59.

CI = CO/BSA where: CO = Cardiac output BSA = Body surface area

6-4 References Cardiac output (CO) in l/min

Oh, J.K., J.B. Seward, A.J. Tajik The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 59.

CO = (SV * HR)/1000 where: CO = Cardiac output SV = Stroke volume HR = Heart rate

Cross sectional area (CSA) in cm2

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 383.

CSA = 0.785 * D2 where: D = diameter of the anatomy of interest

Deceleration time in msec

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 453.

|time a - time b|

Delta pressure: delta time (dP:dT) in mmHg/s

Otto, C.M. Textbook of Clinical Echocardiography. 2nd ed., W.B. Saunders Company, (2000), 117, 118.

32 mmHg/time interval in seconds

E:A ratio in cm/sec

E:A = velocity E/velocity A

E/Ea ratio

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 225.

E Velocity/Ea velocity where: E velocity = Mitral valve E velocity Ea = annular E velocity, also known as: E prime

References 6-5 Effective regurgitant orifice (ERO) in mm2

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 455.

ERO = 6.28 (r2) * Va/MR Vel where: r = radius Va = aliasing velocity

Ejection fraction (EF), percent

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 40.

EF = ((LVEDV – LVESV)/LVEDV) * 100%

where: EF = Ejection fraction LVEDV = Left ventricular end diastolic volume LVESV = Left ventricular end systolic volume

Elapsed time (ET) in msec

ET = time between velocity cursors in milliseconds

Heart rate (HR) in bpm

HR = 3 digit value input by user or measured on M Mode and Doppler image in one heart cycle

Interventricular septum (IVS) fractional thickening, percent

Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71.

IVSFT = ((IVSS – IVSD)/IVSD) * 100% where: IVSS = Interventricular septal thickness at systole IVSD = Interventricular septal thickness at siastole

Isovolumic relaxation time (IVRT) in msec

Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona Heart Institute, (1993), 146.

|time a - time b|

Left atrium/aorta (LA/Ao)

6-6 References Feigenbaum, H. Echocardiography. Philadelphia: Lea and Febiger, (1994), 206, Figure 4-49.

Left ventricular end volumes (Teichholz) in ml

Teichholz, L.E., T. Kreulen, M.V. Herman, et. al. “Problems in echocardiographic volume determinations: echocardiographic-angiographic correlations in the presence or absence of asynergy.” American Journal of Cardiology, (1976), 37:7.

LVESV = (7.0 * LVDS 3)/(2.4 + LVDS) where: LVESV = Left ventricular end systolic volume LVDS = Left ventricular dimension at systole

LVEDV = (7.0 * LVDD 3)/(2.4 + LVDD) where: LVEDV = Left ventricular end diastolic volume LVDD = Left ventricular dimension at siastole

Left ventricular mass in gm

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1999), 39.

LV mass = 1.04 [(LVID + PWT + IVST)3 – LVID3] * 0.8 + 0.6 where: LVID = Internal dimension PWT = Posterior wall thickness IVST = Interventricular septal thickness 1.04 = Specific gravity of the myocardium 0.8 = Correction factor

Left ventricular volume: Biplane method in ml

N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography.” Journal of American Society of Echocardiography. September-October 1989, 2:362.

n  L V = --- a b --- 4  i in i = 1 where: V = Volume in ml a = Diameter b = Diameter

References 6-7 n = Number of segments (n=20) L = Length i = Segment

Left ventricular volume: Single plane method in ml

N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left Ventricle by Two-Dimensional Echocardiography.” Journal of American Society of Echocardiography. September-October 1989, 2:362.

n  2 L V = --- a --- 4  i n i = 1

where: V = Volume a = Diameter n = Number of segments (n=20) L = Length i = Segment

Left ventricular dimension (LVD) fractional shortening, percent

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Boston: Little, Brown and Company, (1994), 43-44.

LVDFS = ((LVDD – LVDS)/LVDD) * 100%

where: LVDD = Left ventricle dimension at diastole LVDS = Left ventricle dimension at systole

Left ventricular posterior wall fractional thickening (LVPWFT), percent

Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71.

LVPWFT = ((LVPWS – LVPWD)/LVPWD) * 100% where: LVPWS = Left ventricular posterior wall thickness at systole LVPWD = Left ventricular posterior wall thickness at diastole

Mean velocity (Vmean) in cm/s

Vmean = mean velocity

Mitral valve area (MVA) in cm2

6-8 References Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 391, 452.

MVA = 220/PHT where: PHT = pressure half time

Note 220 is an empirical derived constant and may not accurately predict mitral valve area in mitral prosthetic heart valves. The mitral valve area continuity equation may be utilized in mitral prosthetic heart valves to predict effective orifice area.

MV flow rate in cc/sec

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 396.

Flow = 6.28 (r2) * Va where: r = radius Va = aliasing Velocity

Pressure gradient (PGr) in mmHG

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott, Williams, and Wilkins, (2007), p.63-66.

PGr = 4 * (Velocity)2 Peak E pressure gradient (E PG) EPG = 4 * PE2 Peak A pressure gradient (A PG) APG = 4 * PA2 Peak pressure gradient (PGmax) PGmax = 4 * PV2 Mean pressure gradient (PGmean)

Echocardiographic Assessment of Valve Stenosis: EAE/ASE Recommendations for Clinical Practice Journal of American Society of Echocardiography, (January, 2009), 4-5.

PG mean = sum(4v2)/N where:

v =peak velocity at interval n N = the number of intervals in the Riemann sum

References 6-9 Pressure half time (PHT) in msec

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 391.

PHT = DT * 0.29

where: DT = deceleration time

Proximal isovelocity surface area (PISA) in cm2

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company, (1999), 125.

PISA = 2 r2

where: 2 = 6.28 r = aliasing radius

Qp/Qs

Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Boston: Philadelphia: Lippincott Williams and Wilkins, (2007), p.70-72.

Qp/Qs = SV Qp site/SV Qs site = RVOT SV/LVOT SV

where:

RVOT SV = RVOT CSA* RVOT VTI = π/4 * RVOT diameter2 * RVOT VTI LVOT SV = LVOT CSA * LVOT VTI = π/4 * LVOT diameter2 * LVOT VTI

Regurgitant fraction (RF) in percent

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Boston: Little, Brown and Company, (1999), 125.

RF = RV/ MV SV

where: RV = Regurgitant Volume MV SV = Mitral Stroke Volume

Regurgitant volume (RV) in cc

Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 396, 455.

RV = ERO * MR VTI

6-10 References Right ventricular systolic pressure (RVSP) in mmHg

Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona Heart Institute, (1993), 152.

RVSP = 4 * (Vmax TR)2 + RAP where: RAP = Right atrial pressure

S/D

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 217.

S velocity/ D velocity where: S velocity = Pulmonary vein S wave D velocity= Pulmonary vein D wave

Stroke index (SI) in cc/m2

Mosby’s Medical, Nursing, & Allied Health Dictionary, 4th ed., (1994), 1492.

SI = SV/BSA where: SV = Stroke volume BSA = Body surface area

Stroke volume (SV) Doppler in ml

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 3rd Edition, Boston: Philadelphia: Lippincott Williams and Wilkins, (2007), p.69-71.

SV = (CSA * VTI) where CSA = Cross sectional area of the orifice (LVOT area) VTI = Velocity time integral of the LVOT

Tricuspid valve area (TVA)

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 55, 391, 452.

TVA = 220 / PHT

References 6-11 Stroke volume (SV) 2D and M Mode in ml

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company, (1994), 44.

SV = (LVEDV – LVESV) where: SV = Stroke volume LVEDV = End diastolic volume LVEDSV = End systolic volume

Velocity time integral (VTI) in cm

Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 383.

VTI = sum of abs (velocities [n]) where: Auto trace – distance (cm) blood travels with each ejection period. Velocities are absolute values.

Obstetrical references

Amniotic fluid index (AFI)

Jeng, C. J., et al. “Amniotic Fluid Index Measurement with the Four Quadrant Technique During Pregnancy.” The Journal of Reproductive Medicine, 35:7 (July 1990), 674-677.

Average ultrasound age (AUA)

The system provides an AUA derived from the component measurements from the measurement tables.

Estimated date of delivery (EDD) by average ultrasound age (AUA)

Results are displayed as month/day/year.

EDD = system date + (280 days – AUA in days)

Estimated date of delivery (EDD) by last menstrual period (LMP)

The date entered into the patient information for LMP must precede the current date.

Results are displayed as month/day/year.

EDD = LMP date + 280 days

6-12 References Estimated fetal weight (EFW)

Hadlock, F., et al. “Estimation of Fetal Weight with the Use of Head, Body, and Femur Measurements, A Prospective Study.” American Journal of Obstetrics and Gynecology, 151:3 (February 1, 1985), 333-337.

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 154.

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 103-105.

Shepard M.J., V. A. Richards, R. L. Berkowitz, et al. “An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound.” American Journal of Obstetrics and Gynecology, 142:1 (January 1, 1982), 47-54.

University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1.

Gestational age (GA) by last menstrual period (LMP)

The gestational age derived from the LMP date entered on the patient information form.

Results are displayed in weeks and days, and is calculated as follows:

GA(LMP) = System date – LMP date

Gestational age (GA) by last menstrual period (LMPd) derived from established due date (Estab. DD)

Same as GA by Estab. DD.

The gestational age derived from the system derived LMP using the established due date entered on the patient information form.

Results are displayed in weeks and days, and is calculated as follows:

GA(LMPd) = System date – LMPd

Last menstrual period derived (LMPd) by established due date (Estab. DD)

Results are displayed as month/day/year.

LMPd(Estab. DD) = Estab. DD – 280 days

Gestational age tables

Abdominal circumference (AC)

References 6-13 Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431.

University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

WARNING The gestational age calculated by your FUJIFILM SonoSite system does not match the age in the aforementioned reference at the 20.0 cm and 30.0 cm abdominal circumference (AC) measurements. The implemented algorithm extrapolates the gestational age from the slope of the curve of all table measurements, rather than decreasing the gestational age for a larger AC measurement indicated in the referenced table. This results in the gestational age always increasing with an increase in AC.

Biparietal diameter (BPD)

Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in Obstetrics and Gynecology 10: (1997), 174-179, Table 3.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 440.

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 98.

University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

Cisterna magna (CM)

Mahony, B.; P. Callen, R. Filly, and W. Hoddick. “The fetal cisterna magna.” Radiology, 153: (December 1984), 773-776.

Crown rump length (CRL)

Hadlock, F., et al. “Fetal Crown-Rump Length: Re-evaluation of Relation to Menstrual Age (5-18 weeks) with High-Resolution, Real-Time Ultrasound.” Radiology, 182: (February 1992), 501-505.

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 439.

6-14 References Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 20 and 96.

Tokyo University. “Gestational Weeks and Computation Methods.” Ultrasound Imaging Diagnostics, 12:1 (1982-1), 24-25, Table 3.

Femur length (FL)

Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in Obstetrics and Gynecology 10: (1997), 174-179, Table 8, 186.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431.

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101-102.

University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 886.

Fetal trunk cross-sectional area (FTA)

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99-100.

Gestational sac (GS)

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986).

Nyberg, D.A., et al. “Transvaginal Ultrasound.” Mosby Yearbook, (1992), 76.

Gestational sac measurements provide a fetal age based on the mean of one, two, or three distance measurements; however, Nyberg’s gestational age equation requires all three distance measurements for an accurate estimate.

Tokyo University. “Gestational Weeks and Computation Methods.” Ultrasound Imaging Diagnostics, 12:1 (1982-1).

Head circumference (HC)

Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in Obstetrics and Gynecology 10: (1997), 174-191, Table 5, 182.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

References 6-15 Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431.

Humerus (HL)

Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. “Estimate of Gestational Age from Measurements of Fetal Long Bones.” Journal of Ultrasound in Medicine. 3: (February 1984), 75-79.

Occipito-frontal diameter (OFD)

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431.

Tibia

Jeanty, P.; F. Rodesch; D. Delbeke; J. E. Dumont. “Estimate of Gestational Age from Measurements of Fetal Long Bones.” Journal of Ultrasound in Medicine. 3: (February 1984), 75-79.

Transverse trunk diameter (TTD)

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 431.

Growth analysis tables

Abdominal circumference (AC)

Chitty, Lyn S. et al. “Charts of Fetal Size: 3. Abdominal Measurements.” British Journal of Obstetrics and Gynaecology 101: (February 1994), 131, Appendix: AC-Derived.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Jeanty P., E. Cousaert, and F. Cantraine. “Normal Growth of the Abdominal Perimeter.” American Journal of Perinatology, 1: (January 1984), 129-135.

(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 179, Table 7.13.)

Biparietal diameter (BPD)

Chitty, Lyn S. et al. “Charts of Fetal Size: 2. Head Measurements.” British Journal of Obstetrics and Gynaecology 101: (January 1994), 43, Appendix: BPD-Outer-Inner.

6-16 References Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Jeanty P., E. Cousaert, and F. Cantraine. “A Longitudinal Study of Fetal Limb Growth.” American Journal of Perinatology, 1: (January 1984), 136-144, Table 5.

(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 176, Table 7.8.)

Estimated fetal weight (EFW)

Brenner, William E.; D. A. Edelman; C. H. Hendricks. “A standard of fetal growth for the United States of America,” American Journal of Obstetrics and Gynecology, 126: 5 (November 1, 1976), 555-564; Table II.

Hadlock F., et al. “In Utero Analysis of Fetal Growth: A Sonographic Weight Standard.” Radiology, 181: (1991), 129-133.

Jeanty, Philippe, F. Cantraine, R. Romero, E. Cousaert, and J. Hobbins. “A Longitudinal Study of Fetal Weight Growth.” Journal of Ultrasound in Medicine, 3: (July 1984), 321-328, Table 1.

(Also published in Hansmann, Hackeloer, Staudach, and Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 186, Table 7.20.)

Femur length (FL)

Chitty, Lyn S. et al. “Charts of Fetal Size: 4. Femur Length.” British Journal of Obstetrics and Gynaecology 101: (February 1994), 135.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

Jeanty P, E. Cousaert, and F. Cantraine. “A Longitudinal Study of Fetal Limb Growth.” American Journal of Perinatology, 1: (January 1984), 136-144, Table 5.

(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 182, Table 7.17.)

Head circumference (HC)

Chitty, Lyn S., et al. “Charts of Fetal Size: 2. Head Measurements.” British Journal of Obstetrics and Gynaecology 101: (January 1994), 43, Appendix: HC-Derived.

Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters.” Radiology, 152: (1984), 497-501.

References 6-17 Jeanty P, E. Cousaert, and F. Cantraine. “A longitudinal study of Fetal Head Biometry.” American J of Perinatology, 1: (January 1984), 118-128, Table 3.

(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in Obstetrics and Gynecology. Springer-Verlag, New York, (1986), 176, Table 7.8.)

Head circumference (HC)/abdominal circumference (AC)

Campbell S., Thoms Alison. “Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation,” British Journal of Obstetrics and Gynaecology, 84: (March 1977), 165-174.

Ratio calculations

FL/AC ratio

Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, and S.K. Park. “A Date Independent Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference Ratio,” American Journal of Roentgenology, 141: (November 1983), 979-984.

FL/BPD ratio

Hohler, C.W., and T.A. Quetel. “Comparison of Ultrasound Femur Length and Biparietal Diameter in Late Pregnancy,” American Journal of Obstetrics and Gynecology, 141:7 (Dec. 1 1981), 759-762.

FL/HC ratio

Hadlock F.P., R. B. Harrist, Y. Shah, and S. K. Park. “The Femur Length/Head Circumference Relation in Obstetric Sonography.” Journal of Ultrasound in Medicine, 3: (October 1984), 439-442.

HC/AC ratio

Campbell S., Thoms Alison. “Ultrasound Measurements of the Fetal Head to Abdomen Circumference Ratio in the Assessment of Growth Retardation,” British Journal of Obstetrics and Gynaecology, 84: (March 1977), 165-174.

General references

+/x or S/D ratio

+/x = abs (Velocity A/Velocity B)

where A = velocity cursor + B = velocity cursor x

6-18 References Acceleration index (ACC)

Zwiebel, W.J. Introduction to Vascular Ultrasonography, 4th ed., W.B. Saunders Company, (2000), 52.

ACC = abs (delta velocity/delta time)

Elapsed time (ET)

ET = time between velocity cursors in milliseconds

Hip angle/d:D ratio

Graf, R. “Fundamentals of Sonographic Diagnosis of Infant Hip Dysplasia.” Journal of Pediatric Orthopedics, Vol. 4, No. 6: 735-740, 1984.

Morin, C., Harcke, H., MacEwen, G. “The Infant Hip: Real-Time US Assessment of Acetabular Development.” Radiology 177: 673-677, December 1985.

Intima media thickness (IMT)

Howard G, Sharrett AR, Heiss G, Evans GW, Chambless LE, Riley WA, et al. “Carotid Artery Intima-Medial Thickness Distribution in General Populations As Evaluated by B-Mode Ultrasound.” ARIC Investigators. Atherosclerosis Risk in Communities. Stroke. (1993), 24:1297-1304.

O’Leary, Daniel H., MD and Polak, Joseph, F., MD, et al. “Use of Sonography to Evaluate Carotid Atherosclerosis in the Elderly. The Cardiovascular Health Study.” Stroke. (September 1991), 22,1155-1163.

Redberg, Rita F., MD and Vogel, Robert A., MD, et al. “Task force #3—What is the Spectrum of Current and Emerging Techniques for the Noninvasive Measurement of Atherosclerosis?” Journal of the American College of Cardiology. (June 4, 2003), 41:11, 1886-1898.

Percent area reduction

Ta ylo r K. J .W ., P.N . B u r ns , P. B re sla u . Clinical Applications of Doppler Ultrasound, Raven Press, N.Y., (1988), 130-136.

Zwiebel W.J., J.A. Zagzebski, A.B. Crummy, et al. “Correlation of peak Doppler frequency with lumen narrowing in carotid stenosis.” Stroke, 3: (1982), 386-391.

% Area reduction = (1 - A2(cm2)/A1(cm2)) * 100 where: A1 = original area of the vessel in square cm A2 = reduced area of the vessel in square cm

Percent diameter reduction

References 6-19 Handa, Nobuo et al., “Echo-Doppler Velocimeter in the Diagnosis of Hypertensive Patients: The Renal Artery Doppler Technique,” Ultrasound in Medicine and Biology, 12:12 (1986), 945-952.

% Diameter reduction = (1 - D2(cm)/D1(cm)) * 100

where: D1 = original diameter of the vessel in cm D2 = reduced diameter of the vessel in cm

Pressure gradient (PGr) in mmHG

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 64.

4 * (Velocity)2

Peak E pressure gradient (E PG)

EPG = 4 * PE2

Peak A pressure gradient (A PG)

APG = 4 * PA2

Peak pressure gradient (PGmax)

PGmax = 4 * PV2

Mean pressure gradient (PGmean)

PGmean = 4 * Vmax2

Pulsatility index (PI)

Kurtz, A.B., W.D. Middleton. Ultrasound-the Requisites. Mosby Year Book, Inc., (1996), 469.

PI = (PSV – EDV)/V

where PSV = peak systolic velocity EDV = end diastolic velocity V = mean flow velocity throughout the entire cardiac cycle

Resistive index (RI)

Kurtz, A.B., W.D. Middleton. Ultrasound-the Requisites. Mosby Year Book, Inc., (1996), 467.

RI = abs ((Velocity A – Velocity B)/Velocity A) in measurements

6-20 References where A = velocity cursor + B = velocity cursor x

Time averaged mean (TAM) in cm/s

TAM = mean (mean Trace)

Time averaged peak (TAP) in cm/s

TAP = peak (peak trace)

Volume (Vol)

Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131.

Volume cm3= (4/3) * Length/2 * Width/2 * Height/2

Volume flow (VF) in ml/m

Allan, Paul L. et al. Clinical Doppler Ultrasound, 4th ed., Harcourt Publishers Limited. (2000), 36-38.

One of the following, depending on the Live Trace setting:

VF = CSA * TAM * .06 VF = CSA * TAP * .06

References 6-21 6-22 References Cleaning and Disinfecting

This chapter includes instructions for cleaning and disinfecting the ultrasound system, transducers, and accessories.

Use the FUJIFILM SonoSite recommendations when cleaning or disinfecting your ultrasound system, transducer, and accessories. Use the cleaning recommendations in the peripheral manufacturer’s instructions when cleaning or disinfecting your peripherals.

See Chapter 2, “Getting Started,”for images of the ultrasound system.

See www.sonosite.com/transducers, for transducer images.

Note The system and transducers must be cleaned and disinfected after each exam. It is important to follow these cleaning and disinfecting instructions without skipping any steps. For cleaning the TEExi transducer, refer to the cleaning and disinfection instructions in the TEExi User Guide.

Before getting started Follow the disinfectant manufacturer’s recommendations regarding appropriate personal protective equipment (PPE), such as protective eyewear and gloves. Inspect the system and transducer to determine that they are free of any unacceptable deterioration, such as corrosion, discoloration, pitting, or cracked seals. If damage is evident, discontinue use, and contact FUJIFILM SonoSite or your local representative. Confirm that cleaning and disinfecting materials are appropriate for your facility’s use. FUJIFILM SonoSite tests cleaners and disinfectants for use with the FUJIFILM SonoSite systems and transducers. Disinfectants and cleaning methods listed in this chapter are recommended by FUJIFILM SonoSite for efficacy and material compatibility with the products. Ensure that the disinfectant type and the solution strength and duration are appropriate

CHAPTER 7 for the equipment and application.

Cleaning and Disinfecting 7-1 Follow manufacturer recommendations and local regulations, when preparing, using and disposing of chemicals.

WARNINGS Ensure that cleaning and disinfecting solutions and wipes are not expired Some cleaners and disinfectants can cause an allergic reaction in some individuals

Cautions Do not allow cleaning solution or disinfectant into the system connectors, or transducer connector. Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since these will damage the exterior surfaces. Use only FUJIFILM SonoSite recommended cleaners or disinfectants.

Determining the required cleaning and disinfecting level

WARNING The cleaning instructions contained in this chapter are based on requirements mandated by the U.S. Food and Drug Administration (FDA). Failure to follow these instructions may result in cross contamination and patient infection.

The level of cleaning and disinfecting required for the system is dictated by the type of tissue it contacts during use. Use Table 7-22 to determine the level of cleaning and disinfecting required.

Table 7-22: Choosing a cleaning and disinfecting method

Did any part of the system or transducer come in contact with broken skin, blood, mucosal membranes, or bodily fluids?

Came in contact with broken Option A YES skin, blood, mucosal membranes, or bodily fluids. Go to “Clean and disinfect system and transducer to a high level (semi-critical uses)” on page 7-3. OR

Did not come in contact with Option B NO broken skin, blood, or bodily fluids. Go to “Clean and disinfect system and transducer to a low level (non-critical uses)” on page 7-8.

7-2 Cleaning and Disinfecting Spaulding classifications

Spaulding classifications (non-critical, semi-critical) determine the approach for cleaning and disinfecting medical equipment based on the device, the way it has been used, and the risk of infection. The system and transducers are designed for use within the Spaulding classifications of non-critical and semi-critical uses.

Option A Clean and disinfect system and transducer to a high level (semi-critical uses)

Use this procedure to clean and high-level disinfect the ultrasound system and transducer whenever it has come into contact with blood, broken skin, mucosal membranes, or bodily fluids.

Follow the manufacturer's instructions when using cleaners and disinfectants. The cleaners and disinfectants listed in the procedure are both chemically compatible and have been tested for efficacy with the system and transducers. Confirm that the cleaners and disinfectants are appropriate for your facility’s use.

WARNINGS To avoid electrical shock, before cleaning, disconnect the system from the power supply. Wear the appropriate personal protective equipment (PPE) recommended by the chemical manufacturer, such as eyewear and gloves.

Cautions Do not skip any steps or abbreviate the cleaning and disinfecting process in any way. Do not spray cleaners or disinfectants directly on the system surfaces or on system and transducer connectors. Doing so may cause solution to leak into the system, damaging it and voiding the warranty. Do not attempt to disinfect a transducer or transducer cable using a method or chemical that is not included here. This can damage the transducer and void the warranty. Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a non- recommended disinfecting solution or incorrect solution strength can damage the system and transducer and void the warranty. Follow the disinfectant manufacturer’s recommendations for solutions strengths.

Note You must clean and disinfect both the ultrasound system and the transducer after each use, but only the transducer can be disinfected to a high level.

To clean and disinfect the system and transducer 1 Turn off the system by pressing the Power button.

Cleaning and Disinfecting 7-3 2Unplug the power cord from the outlet. 3Remove the disposable transducer sheath, if applicable. 4 Disconnect the transducer from the system. Temporarily place it where it will not cross-contaminate clean equipment or surfaces while you clean the ultrasound console. 5Clean the exterior surfaces of the ULTRASOUND SYSTEM to remove any debris or bodily fluids. Use the following procedure: a Use either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner from the list of approved cleaners. Table 7-23: Approved cleaners/disinfectants for the ultrasound system

Cleaner/disinfectant Compatible systems Minimum wet contact time1

SaniCloth Plus SonoSite Edge 3 minutes SonoSite M-Turbo PI-Spray II SonoSite S Series 10 minutes

1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period of time. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a more complete list of approved cleaners and disinfectants.

b Remove all gel, debris, and bodily fluids from the system. c With a new wipe, clean the system, including the display, by wiping from clean areas to the soiled areas. This method helps to avoid cross-contamination. d Observe the minimum wet contact time recommended by the manufacturer. Monitor the system for wet appearance. Re-apply with a new wipe if no longer wet. e Allow the ultrasound system to air dry in a clean, well-ventilated space. 6 Clean the ultrasound system STAND to remove any debris or bodily fluids. For information about cleaning the stand, see the H-Universal Stand User Guide. 7 Clean the TRANSDUCER CABLE AND BODY to remove any debris or bodily fluids. Use the following procedure:

7-4 Cleaning and Disinfecting a Use either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner from the list of approved cleaners. Table 7-24: Approved cleaners/disinfectants for the transducer

Product Compatible transducer Minimum wet contact time1

Sani-Cloth AF32 C11x, C60x, C60xi, C8x, 3 minutes HFL38x, HFL50x, ICTx, L25x, L38xi, P10x, P21x

Sani-Cloth Plus HFL50x 3 minutes

PI-Spray II C11x, C60x, C60xi, C8x, 10 minutes HFL38x, HFL50x, ICTx, L25x, L38xi, P10x, P21x

1For maximum effectiveness, the component being cleaned must remain wet with disinfec- tant for a minimum period of time. 2 Qualified for use as an intermediate-level disinfectant for mycobacteria. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/clean- ers-disinfectants for a more complete list of approved cleaners and disinfectants.

b Remove all gel, debris, and bodily fluids from the transducer. c With a new wipe, clean the cable and transducer, starting from the cable, wiping toward the scanhead. This method helps to avoid cross-contamination.

Caution Do not allow moisture near the electronic components of the connector.

d Observe the minimum wet contact time recommended by the manufacturer. Monitor the transducer for wet appearance. Re-apply with a new wipe if no longer wet. 8Verify that all gel, debris, and bodily fluids have been removed from the system and transducer. If necessary, repeat steps 5, 6, and 7 with a new wipe.

WARNING Failure to remove all gel, debris, and bodily fluid could leave contaminants on the probe.

Cleaning and Disinfecting 7-5 9 Examine the system, transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use and contact FUJIFILM SonoSite or your local representative. 10 Prepare the disinfectant for use. a Choose a high-level disinfectant from the list of approved disinfectants. Table 7-25: High-level disinfectants compatible with SonoSite M-Turbo transducers

Disinfectant Compatible transducers Temperature Disinfectant soak duration

Cidex C11x, C60x, C60xi, C8x, 25oC, 77oF 45 minutes HFL38x, HFL50x, ICTx, L25x, L38xi, P10x, P21x

Cidex OPA C11x, C60x, C60xi, C8x, 20oC, 68oF 12 minutes HFL38x, HFL50x, L25x, L38xi, P10x, P21x

Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a more complete list of the most current approved cleaners and disinfectants.

b Check the expiration date on the bottle to ensure the disinfectant has not expired. c Mix or check that the disinfection chemicals have the concentration recommended by the manufacturer (for example, a chemical strip test). d Check that the temperature of the disinfectant is within the manufacturer’s recommended limits. 11 Perform a high-level disinfection of the transducer. Use the following procedure: a Immerse the transducer in a high-level disinfectant solution.

WARNING High-level disinfectants can cause harm to the patient if not completely removed from the transducer. Follow the manufacturer’s rinse instructions to remove chemical residue.

Cautions Do not soak the transducer longer than recommended by the chemical manufacturer. Do not immerse the transducer connector in any disinfectant solution. Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a non-recommended disinfecting solution or incorrect solution strength can damage or discolor the transducer and void the warranty.

7-6 Cleaning and Disinfecting b Ensure that the connector and most of the cable remain out of the fluid. You may submerge 2 inches (5 cm) of the cable proximal to the transducer scanhead. Connector

Cable

Maximum 5 cm Do not submerge (2 inches)

Scan head

Figure 7-3 Transducer component names

12 Rinse the transducer three separate times using the following procedure:

WARNING High-level disinfectants can cause harm to the patient if not completely removed from the transducer. Follow the manufacturer’s rinse instructions to remove chemical residue.

a Rinse the transducer in clean, running water according to the disinfectant manufacturer’s instructions (at least one minute). b Ensure that the connector and at least 12-18 inches (31-46 cm) of the cable from the connector remain dry. c Repeat this step until the transducer has been rinsed three separate times. 13 Dry the transducer with a sterile lint-free cloth. 14 Dispose of the disinfectant according to the manufacturer’s guidelines.

Cleaning and Disinfecting 7-7 Option B Clean and disinfect system and transducer to a low level (non-critical uses)

Use the following procedure to clean and disinfect the ultrasound system and transducer if it has not come into contact with blood, broken skin, mucosal membranes, or bodily fluids.

WARNING If the system or transducer has come into contact with any of the following, use the high-level cleaning and disinfection procedure. See “Clean and disinfect system and transducer to a high level (semi-critical uses)” on page 7-3: Blood Broken skin Mucosal membranes Bodily fluids

Follow the manufacturer's instructions when using cleaners and disinfectants. The cleaners and disinfectants listed in the procedure are both chemically compatible and have been tested for efficacy with the system and transducers. Confirm that the cleaners and disinfectants are appropriate for your facility’s use.

WARNINGS To avoid electrical shock, before cleaning, disconnect the system from the power supply. Wear the appropriate personal protective equipment (PPE) recommended by the chemical manufacturer, such as eyewear and gloves.

Cautions Do not spray cleaners or disinfectants directly on the system surfaces or on system and transducer connectors. Doing so may cause solution to leak into the system, damaging it and voiding the warranty. Use only FUJIFILM SonoSite-recommended cleaners and disinfectants. Using a non-recommended disinfecting solution or incorrect solution strength can damage the system and transducer and void the warranty. Follow the disinfectant manufacturer’s recommendations for solutions strengths. Do not attempt to disinfect a transducer or transducer cable using a method or chemical that is not included here. Doing so can damage the transducer and void the warranty.

To clean and disinfect the system and transducer 1 Turn off the system by pressing the Power button. 2Unplug the power cord from the outlet. 3Remove the transducer sheath, if applicable.

7-8 Cleaning and Disinfecting 4 Disconnect the transducer from the system. Temporarily place it where it will not cross-contaminate clean equipment or surfaces while you clean the ultrasound system. 5Clean the exterior surfaces of the ULTRASOUND SYSTEM to remove any debris. Use the following procedure: a Use either a pre-moistened wipe or a soft cloth dampened with cleaner and disinfectant. Choose a cleaner from the list of approved cleaners. Table 7-26: Approved cleaners/disinfectants for the ultrasound system:

Cleaner/disinfectant Compatible systems Minimum wet contact time1

SaniCloth Plus SonoSite Edge 3 minutes SonoSite M-Turbo PI-Spray II SonoSite S Series 10 minutes

1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period of time. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a more complete list of the most current approved cleaners and disinfectants.

b Remove all gel and debris from the system. c With a new wipe, clean the system, including the display, by wiping from clean areas to the soiled areas. This method helps to avoid cross-contamination. d Observe the minimum wet contact time and refer to manufacturer’s instructions. Monitor the system for wet appearance. Re-apply with a new wipe if no longer wet. 6Clean the ultrasound system STAND to remove any debris. For information about cleaning the stand, see the Edge Stand and H-Universal Stand User Guide. 7Clean the TRANSDUCER CABLE AND BODY to remove any debris. Use the following procedure: a Use either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner from the list of approved cleaners. Table 7-27: Approved cleaners/disinfectants for the transducer:

Product Compatible transducer Minimum wet contact time1

Sani-Cloth AF32 C11x, C60x, C60xi, C8x, 3 minutes HFL38x, HFL50x, ICTx, L25x, L38xi, P10x, P21x

Sani-Cloth Plus HFL50x 3 minutes

1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period of time. 2 Qualified for use as an intermediate-level disinfectant for mycobacteria. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a more complete list of the most current approved cleaners and disinfectants.

Cleaning and Disinfecting 7-9 Table 7-27: Approved cleaners/disinfectants for the transducer:

Product Compatible transducer Minimum wet contact time1

PI-Spray II C11x, C60x, C60xi, C8x, 10 minutes HFL38x, HFL50x, ICTx, L25x, L38xi, P10x, P21x

1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period of time. 2 Qualified for use as an intermediate-level disinfectant for mycobacteria. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a more complete list of the most current approved cleaners and disinfectants.

b Remove all gel and debris from the transducer. c With a new wipe, clean the cable and transducer, starting from the cable, wiping toward the scanhead. This method helps to avoid cross-contamination.

Caution Do not allow moisture near the electronic components of the connector.

d Observe the minimum wet contact time recommended by the manufacturer. Monitor the transducer for wet appearance. Re-apply with a new wipe if no longer wet. 8Verify that all gel and debris have been removed from the system and transducer. If necessary, repeat steps 5, 6, and 7 with a new wipe. Allow the ultrasound system to air dry in a clean, well-ventilated space.

WARNING Failure to remove all gel and debris could leave contaminants on the probe.

9 Examine the system, transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use, and contact FUJIFILM SonoSite or your local representative..

Storing the transducer To store the transducer 1 Make sure the transducer has been cleaned and disinfected as detailed in the previous section. 2 Store the transducer so that it hangs freely and vertically, and observe the following precautions: Store the transducer away from any contaminated transducers.

7-10 Cleaning and Disinfecting Store the transducer in an environment that is safe and has good airflow. Do not store the transducer in closed containers or where condensation may occur. Avoid direct sunlight and exposure to x-rays. Recommended storage temperature range is between 0o C (32o F) and +45o C (113o F). If using a wall-mounted rack for storage, ensure that: It is securely mounted. The storage slots do not mar the transducer or cause damage to the cable. The rack is sized and positioned to prevent the transducer from inadvertently falling. Make sure the connector is supported and secure.

Transporting the transducer

When transporting the transducer, you must take precautions to protect the transducer from damage and avoid cross-contamination. Be sure to use a container approved by your organization.

To transport a soiled transducer for cleaning

A soiled transducer is one that has been contaminated and must be cleaned before using it in an exam.

1 Place the transducer in a clean, approved container.

WARNING To prevent cross-contamination or unprotected exposure of personnel to biological material, containers used to transport contaminated transducers should carry an ISO biohazard label similar to the following:

Caution Ensure the transducer is dry before placing it in a closed container. Condensation from a damp transducer can damage the connector.

2 Transport the transducer in the container to the point of processing. Do not open the container until the transducer is ready to be cleaned.

Caution Do not leave the transducer in a sealed container for long periods of time.

To transport a clean transducer

A clean transducer is one that has completed the cleaning and disinfection process, has been stored properly, and is ready to be used in an examination.

Cleaning and Disinfecting 7-11 1 Place the transducer in a clean, approved container. To identify the transducer as clean, containers used to transport clean transducers should carry a cleanliness verification sticker or certificate. 2 Transport the transducer in the container to the point of use. Do not open the container until the transducer is ready to be used. To ship a transducer

WARNING Whenever possible, avoid shipping a contaminated transducer. Before shipping, ensure the transducer has been cleaned and disinfected using the steps detailed in this chapter or according to special instructions received from FUJIFILM SonoSite. If you are returning the transducer to FUJIFILM SonoSite, document the disinfection on a “Declaration of Cleanliness,” and attach it to the packing list.

1 Place the transducer in the shipping container and seal it. Do not allow any part of the transducer to protrude from the container. 2 Ship the transducer using the following precautions: Clearly label the container as fragile. Do not stack items on top of the shipping container. Do not exceed the shipping temperature range: -35o C (-31o F) to +65o C (149o F). Do not open the shipping container until it reaches its final destination. After arrival, the transducer must be cleaned and disinfected before it can be used in an exam.

Cleaning the stand

For information about cleaning the stand, see the H-Universal Stand User Guide.

Cleaning the footswitch

Caution To avoid damaging the footswitch, do not sterilize. It is not intended for use in a sterile environment.

To clean the footswitch 1 Dampen a non-abrasive cloth with one of the following products: Isopropyl alcohol Soap and water Cidex Sodium Hypochlorite 5.25% (Bleach) diluted 10:1 2 Wring out cloth until slightly wet and then gently rub soiled area until clean.

7-12 Cleaning and Disinfecting Cleaning and disinfecting accessories

To clean and disinfect the ECG slave cable, refer to the ECG Slave Cable User Guide.

Cleaning and Disinfecting 7-13 7-14 Cleaning and Disinfecting Troubleshooting and Maintenance

This chapter contains information to help correct problems with system operation, to enter a software license, and to take proper care of the system, transducer, and accessories.

Troubleshooting

If you encounter difficulty with the system, use the following list to help troubleshoot the problem. If the problem persists, contact FUJIFILM SonoSite technical support. (See “Getting help” on page 1-3.)

System does not turn on. Check all power connections.

Remove the DC input connector and battery, wait 10 seconds, and then reinstall them.

Ensure that the battery is charged.

System displays the alert “Incompatible power supply . . . “ Use the power supply that shipped with the system. See “Compatible accessories and peripherals” on page 9-14.

System image quality is poor. Adjust the display to improve viewing angle.

Adjust the brightness.

Adjust the gain.

No CPD image. Adjust the gain.

No Color image. Adjust the gain or the PRF scale.

No OB measurement selections. Select the OB exam type.

System displays the alert “Maximum number of procedure entries reached” when CHAPTER 8 trying to create a patient information form. Free up internal-storage space by archiving or exporting patient exams and then deleting them from the system.

Troubleshooting and Maintenance 8-1 System displays the alert “Unable to save image or clip. You have reached the maximum number of images/clips allowed for a single patient.” Delete any unwanted images or clips from the patient exam.

Print does not work.Select the printer on the Connectivity setup page. See “To configure the system for a printer” on page 3-8.

Check the printer connections.

Ensure that the printer is turned on and set up properly. See the printer manufacturer’s instructions, if necessary.

DVD recorder does not record. Check the DVD recorder connections.

Ensure that the DVD recorder is turned on and set up properly. See the applicable FUJIFILM SonoSite accessory user guide and the manufacturers’ instructions.

External monitor does not work. Check the monitor connections. Check the monitor to ensure that it is turned on and set up properly. See the monitor manufacturers’ instructions, if necessary.

System displays the alert “The external video is not functional . . .” Make sure that the system is securely attached to the dock.

System does not recognize the transducer. Disconnect and reconnect the transducer.

System prompts you to “ensure the USB device is valid.” Make sure that the USB storage device does not have password protection enabled and is not defective.

Use the USB storage device included with the system.

System prompts you to “ensure the USB device contains valid data.” Make sure that the data is present on the USB storage device.

Reexport the original data onto the USB storage device.

Contact your system administrator.

A maintenance icon appears on the system screen. Restart the system. If the issue recurs, system maintenance may be required. Note the number that appears in parentheses on the C: line and contact FUJIFILM SonoSite or your FUJIFILM SonoSite representative.

Software licensing

FUJIFILM SonoSite software is controlled by a license key. After you install new software, the system prompts you for a license key. You must obtain one key for each system or transducer that uses the software.

8-2 Troubleshooting and Maintenance The software will operate for a short time (the grace period) without a license key. During the grace period, all system functions are available. After the grace period, the system is not usable until you enter a valid license key. Grace period time is not used while the system is off or asleep. Grace period time remaining appears on the license update screen.

Caution After the grace period expires, all system functions except licensing are unavailable until a valid license key is entered.

To obtain a license key for your software, contact FUJIFILM SonoSite Technical Support. (See “Getting help” on page 1-3.) You need to provide the following information. (See “System information setup” on page 3-14.)

Table 8-28: System and transducer software

System software Transducer software

Name of person installing the upgrade Name of person installing the upgrade

Serial number (on bottom of system) Transducer serial number

ARM version Transducer part number (REF) or model number (for example, C60x)

PCBA serial number Transducer bundle version

After you obtain a license key, you must enter it into the system.

To enter a license key 1 Turn on the system.

The license update screen appears. 2 Enter the license key in the Enter license number field.

3 Select Done on-screen.

If you entered a valid license key but the license update screen appears, verify that you entered the license key correctly. If the license update screen still appears, contact FUJIFILM SonoSite technical support. (See “Getting help” on page 1-3.)

Troubleshooting and Maintenance 8-3 Maintenance

WARNINGS No modification of this equipment, except as described in this manual or the FUJIFILM SonoSite M-Turbo Service Manual, is allowed.

Do not service or perform maintenance procedures on the system while it is in use with a patient.

No periodic or preventive maintenance is required for the system, transducer, or accessories other than cleaning and disinfecting the transducer after every use. There are no internal components that require periodic testing or calibration. All maintenance requirements are described in this chapter and in the ultrasound system service manual.

Note Performing maintenance procedures not described in the user guide or service manual may void the product warranty.

Contact FUJIFILM SonoSite technical support for any maintenance questions. Refer to “Getting help” on page 1-3.

Cleaning and disinfecting the battery

Caution To avoid damaging the battery, do not allow cleaning solution or disinfectant to come in contact with the battery terminals.

To clean and disinfect a battery (wipe method) 1 Remove the battery from the system.

2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution.

Apply the solution to the cloth rather than the surface. 3 Wipe the surfaces with the disinfection solution. Sani-Cloth HB, Sani-Cloth Wipes, or 70% isopropyl alcohol is recommended.

Air dry.

8-4 Troubleshooting and Maintenance Safety

This chapter contains information required by regulatory agencies, including information about the ALARA (as low as reasonably achievable) principle, the output display standard, acoustic power and intensity tables, and other safety information. The information applies to the ultrasound system, transducer, accessories, and peripherals.

Ergonomic safety

These healthy scanning guidelines are intended to assist you in the comfort and effective use of your ultrasound system.

WARNINGS To prevent musculoskeletal disorders, follow the guidelines in this section.

Use of an ultrasound system may be linked to musculoskeletal disorders (MSDs)1,2,3.

Use of an ultrasound system is defined as the physical interaction between the operator, the ultrasound system, and the transducer.

When using an ultrasound system, as with many similar physical activities, you may experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back, or other parts of your body. However, if you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified health professional. Symptoms such as these can be linked with MSDs. MSDs can be painful and may result in potentially disabling injuries to the nerves, muscles, tendons, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and CHAPTER 9 tendonitis.

Safety 9-1 While researchers are not able to definitively answer many questions about MSDs, there is a general agreement that certain factors are associated with their occurrence including preexisting medical and physical conditions, overall health, equipment and body position while doing work, frequency of work, duration of work, and other physical activities that may facilitate the onset of MSDs4. This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDs5,6.

1. Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. “Work-related Musculoskeletal Complaints in Sonologists.” Occupational Environmental Medicine. 41:11 (1999), 981-988. 2. Craig, M. “Sonography: An Occupational Hazard?” Journal of Diagnostic Medical Sonography. 3 (1985), 121-125. 3. Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Musculoskeletal Pain in Cardiac Ultrasonographers: Results of a Random Survey.” Journal of American Society of Echocardiography. (May1997), 357-362. 4. Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta.” International Journal of Industrial Ergonomics. 19 (1997), 205-216. 5. Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New Jersey. (1999). 6. Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610.

Position the system

Promote comfortable shoulder, arm, and hand postures Use a stand to support the weight of the ultrasound system. Minimize eye and neck strain If possible, position the system within reach. Adjust the angle of the system and display to minimize glare. If using a stand, adjust its height so that the display is at or slightly below eye level.

Position yourself

Support your back during an exam Use a chair that supports your lower back, that adjusts to your work surface height, that promotes a natural body posture, and that allows quick height adjustments. Always sit or stand upright. Avoid bending or stooping. Minimize reaching and twisting Use a bed that is height adjustable.

9-2 Safety Position the patient as close to you as possible. Face forward. Avoid twisting your head or body. Move your entire body front to back, and position your scanning arm next to or slightly in front of you. Stand for difficult exams to minimize reaching. Position the ultrasound system or display directly in front of you. Provide an auxiliary monitor for patient viewing. Promote comfortable shoulder and arm postures Keep your elbow close to your side. Relax your shoulders in a level position. Support your arm using a support cushion or pillow, or rest it on the bed. Promote comfortable hand, wrist, and finger postures Hold the transducer lightly in your fingers. Minimize the pressure applied on the patient. Keep your wrist in a straight position.

Take breaks, exercise, and vary activities Minimizing scanning time and taking breaks can effectively allow your body to recover from physical activity and help you avoid MSDs. Some ultrasound tasks may require longer or more frequent breaks. However, simply changing tasks can help some muscle groups relax while others remain or become active. Work efficiently by using the software and hardware features correctly. Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm, and leg positions. Do targeted exercises. Targeted exercises can strengthen muscle groups, which may help you avoid MSDs. Contact a qualified health professional to determine stretches and exercises that are right for you.

Safety 9-3 Electrical safety classification

Class I equipment The ultrasound system is classified as Class I equipment when powered from the external power supply or mounted on the stand because the external power supply is a Class 1 protectively earthed power supply. The stand has no protective earth. Ground bond testing is not applicable to the ultrasound system or the stand.

Note AC powered peripherals that may be used with the system are Class I and are individually protectively earthed. Ground bond testing may be conducted on each AC powered peripheral.

Internally powered Ultrasound system not connected to the power supply equipment (battery only)

Type BF applied parts Ultrasound transducers

Type CF applied parts ECG module/ECG leads

IPX-7 (watertight equipment) Ultrasound transducers

IPX-8 (watertight equipment) Footswitch

Non AP/APG Ultrasound system power supply, docking system, and peripherals. Equipment is not suitable for use in the presence of flammable anesthetics.

Electrical safety

This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF and Type CF isolated patient-applied parts safety requirements.

This system complies with the applicable medical standards as listed in the Standards section of this document. Refer to “Standards” on page 10-4

For maximum safety observe the following warnings and cautions.

WARNINGS To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the patient.

9-4 Safety Avoid patient contact with any part of the system other than the transducer or ECG leads.

Under certain circumstances, the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system. This does not include the transducer face.

To avoid discomfort or minor risk of operator injury when handling the transducer connector, the system should not be operated for more than 60 minutes continuously in a live-scan mode (as opposed to freeze or sleep modes).

To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. Explosion can result.

To avoid the risk of electrical shock or injury, do not open the system enclosures. All internal adjustments and replacements, except battery replacement, must be made by a qualified technician.

To avoid the risk of electrical shock, do not allow any part of the system (including the bar code scanner, external mouse, power supply, power supply connector, external keyboard, and so on), except for the transducer or ECG leads, to touch the patient.

To avoid the risk of electrical shock: This equipment must be connected only to a supply mains with protective earth. Use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked “Hospital Only” or “Hospital Grade” or the equivalent. The grounding wire must not be removed or defeated. When using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt, operate the system on battery power only without using the power supply. Do not touch any of the following: The ungrounded signal input/output connectors on the back of the ultrasound system. The system battery contacts (inside the battery compartment). The system transducer connector when the transducer or Triple Transducer Connect (TTC) is disconnected. The system transducer connector on the triple transducer connector if no transducers are connected.

Safety 9-5 Do not connect the system’s power supply or a docking system to an MPSO or extension cord. Before using the transducer, inspect the transducer face, housing, and cable. Do not use the transducer if the transducer or cable is damaged. Always disconnect the power supply from the system before cleaning the system. Do not use any transducer that has been immersed beyond the specified cleaning or disinfection level. See Chapter 7, “Cleaning and Disinfecting.” Use only accessories and peripherals recommended by FUJIFILM SonoSite, including the power supply. Connection of accessories and peripherals not recommended by FUJIFILM SonoSite could result in electrical shock. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommend by FUJIFILM SonoSite. Use commercial grade peripherals recommended by FUJIFILM SonoSite on battery power only. Do not connect these products to AC mains power when using the system to scan or diagnose a patient/subject. Contact FUJIFILM SonoSite or your local representative for a list of the commercial grade peripherals available from or recommended by FUJIFILM SonoSite.

To avoid the risk of electrical shock and fire hazard: Inspect the power supply, AC power cords, cables, and plugs on a regular basis. Ensure that they are not damaged. The power cord set that connects the power supply of the ultrasound system or MDS to mains power must only be used with the power supply or docking system, and cannot be used to connect other devices to mains power.

To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse.

To avoid possible electrical shock or electromagnetic interference, verify proper operation and compliance with relevant safety standards for all equipment before clinical use.

Connecting additional equipment to the ultrasound system constitutes configuring a medical system. FUJIFILM SonoSite recommends verifying that the system, all combinations of equipment, and accessories connected to the ultrasound system comply with the safety standards and installation requirements as applicable at the site of installation.

Do not use shielded Ethernet cables with metal connector housings, as they may increase system touch current when connected to other equipment.

9-6 Safety To avoid applying unsafe voltage levels to the patient while a device is connected to the external VGA or digital video out port, do not touch the ultrasound system and the patient simultaneously. Check the electrical safety of your system with a trained biomedical engineer.

Cautions Do not use the system if an error message appears on the image display: note the error code; call FUJIFILM SonoSite or your local representative; turn off the system by pressing and holding the power key until the system powers down.

To avoid increasing the system and transducer connector temperature, do not block the airflow to the ventilation holes on the side of the system.

Equipment safety

To protect your ultrasound system, transducer, and accessories, follow these precautions.

Cautions Excessive bending or twisting of cables can cause a failure or intermittent operation.

Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 7, “Cleaning and Disinfecting.”

Do not submerge the transducer connector in solution. The cable is not liquid-tight beyond the transducer connector/cable interface.

Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system.

Remove the battery from the system if the system is not likely to be used for some time.

Do not spill liquid on the system.

Safety 9-7 Battery safety

To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage, observe the following precautions.

WARNINGS Periodically, check to make sure that the battery charges fully. If the battery fails to charge fully, replace it.

Do not ship a damaged battery without instructions from FUJIFILM SonoSite Technical Support.

Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects.

Do not touch battery contacts.

Do not heat the battery or discard it in a fire.

Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire and other heat sources.

Do not charge the battery near a heat source, such as a fire or heater.

Do not leave the battery in direct sunlight.

Do not pierce the battery with a sharp object, hit it, or step on it.

Do not use a damaged battery.

Do not solder a battery.

The polarity of the battery terminals are fixed and cannot be switched or reversed. Do not force the battery into the system.

Do not connect the battery to an electrical power outlet.

Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles.

If the battery leaks or emits an odor, remove it from all possible flammable sources.

Cautions To avoid the battery becoming damaged and causing equipment damage, observe the following precautions:

9-8 Safety Do not immerse the battery in water or allow it to get wet.

Do not put the battery into a microwave oven or pressurized container.

If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult FUJIFILM SonoSite or your local representative.

Store the battery between -20°C (-4°F) and 60°C (140°F).

Use only FUJIFILM SonoSite batteries.

Do not use or charge the battery with non-FUJIFILM SonoSite equipment. Only charge the battery with the system.

Safety 9-9 Clinical safety

WARNINGS Non-medical (commercial) grade peripheral monitors have not been verified or validated by FUJIFILM SonoSite as being suitable for diagnosis.

FUJIFILM SonoSite does not recommend the use of high-frequency electromedical devices in proximity to its systems. FUJIFILM SonoSite equipment has not been validated for use with high-frequency electrosurgical devices or procedures. Use of high-frequency electrosurgical devices in proximity to its systems may lead to abnormal system behavior or shutdown of the system.

To avoid the risk of a burn hazard, do not use the transducer with high frequency surgical equipment. Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection.

The maximum temperature of the transducer scan head may be greater than 41 °C (105.8 °F), but is less than 43 °C (109.4 °F) when in contact with the patient. Special precautions should be considered when using the transducer on children or on other patients who are sensitive to higher temperatures.

Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use.

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber.

Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle and follow the prudent use information concerning MI and TI.

FUJIFILM SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz.

Some FUJIFILM SonoSite transducers are approved for intraoperative applications if a market-cleared sheath is used.

9-10 Safety To avoid injury or reduce the risk of infection to the patient, observe the following: Follow Universal Precautions when inserting and maintaining a medical device for interventional and intraoperative procedures. Appropriate training in Interventional and Intraoperative procedures as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer is required. During vascular access, the potential exists for serious complications including without limitation the following: pneumothorax, arterial puncture, guide-wire misplacement, and risks normally associated with local or general anesthesia, surgery, and post-operative recovery.

To avoid device damage or patient injury, do not use the P10x, P17x, or P21x needle guide bracket on patients with pacemakers or medical electronic implants. The needle guide bracket for the P10x, P17x, and P21x transducers contains a magnet that is used to ensure the bracket is correctly oriented on the transducer. The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect.

Hazardous materials

WARNING Products and accessories may contain hazardous materials. Ensure that products and accessories are disposed of in an environmentally responsible manner and meet federal and local regulations for disposing hazardous materials.

Electromagnetic compatibility

The ultrasound system has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

Cautions Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. ESD is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats.

Safety 9-11 Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the ultrasound system. Evidence of disruption may include image degradation or distortion, erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs, survey the site to determine the source of disruption, and take the following actions to eliminate the source(s).

Turn equipment in the vicinity off and on to isolate disruptive equipment. Relocate or re-orient interfering equipment. Increase distance between interfering equipment and your ultrasound system. Manage use of frequencies close to ultrasound system frequencies. Remove devices that are highly susceptible to EMI. Lower power from internal sources within facility control (such as paging systems). Label devices susceptible to EMI. Educate clinical staff to recognize potential EMI-related problems. Eliminate or reduce EMI with technical solutions (such as shielding). Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI. Share relevant EMI information with others, particularly when evaluating new equipment purchases which may generate EMI. Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.

To avoid the risk of increased electromagnetic emissions or decreased immunity, use only accessories and peripherals recommended by FUJIFILM SonoSite. Connection of accessories and peripherals not recommended by FUJIFILM SonoSite to the ultrasound system may result in malfunction of the ultrasound system or other medical electrical devices in the area. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM SonoSite. See the FUJIFILM SonoSite accessories user guide.

WARNINGS The SonoSite M-Turbo ultrasound system should not be used adjacent to or stacked with other equipment. If such use occurs, verify that the SonoSite M-Turbo ultrasound system operates normally in that configuration.

9-12 Safety WARNINGS Unless following ESD precautionary procedures, do not connect to or touch (with body or hand-held tools) pins (contacts) of connectors that have the ESD Sensitive Devices label (such as the transducer connector):

Electrostatic Sensitive Devices Label

Pins (contacts) on transducer and back of TTC connector

Pins (contacts) on the back of the Triple Transducer Connect (TTC)

Pins (contacts) on the system

If the symbol is on a border surrounding multiple connectors, the symbol pertains to all connectors within the border. ESD precautionary procedures include the following: All staff involved must receive training about ESD, including the following at a minimum: an explanation of the ESD warning symbol, ESD precautionary procedures, an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice, and the damage that can occur to electronic components if equipment is touched by an individual who is electrostatically charged (IEC 60601-1-2, section 5.2.1.2 d). Prevent the buildup of electrostatic charge. For example, use humidification, conductive floor coverings, nonsynthetic clothing, ionizers, and minimizing insulating materials. Discharge your body to earth. Use a wrist strap to bond yourself to the ultrasound system or to earth.

Separation distance

The SonoSite M-Turbo ultrasound system is intended for use in an electromagnetic environment in which radiated radio frequency (RF) disturbances are controlled. The customer or the user of the SonoSite M-Turbo ultrasound system can help prevent electromagnetic interference by maintaining a minimum distance

Safety 9-13 between portable and mobile RF communications equipment (transmitters) and the SonoSite M-Turbo ultrasound system as recommended below, according to the maximum output power of the communications equipment.

Table 9-29: Recommended separation distances between portable and mobile RF communications equipment and the SonoSite M-Turbo ultrasound system

Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Watts d=1.2 P d=1.2 P d=2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Compatible accessories and peripherals

FUJIFILM SonoSite has tested the SonoSite M-Turbo ultrasound system with the following accessories and peripherals and has demonstrated compliance to the requirements of IEC60601-1-2:2007.

You may use these FUJIFILM SonoSite accessories and third-party peripherals with the SonoSite M-Turbo ultrasound system.

WARNINGS Use of the accessories with medical systems other than the SonoSite M-Turbo ultrasound system may result in increased emissions or decreased immunity of the medical system.

Use of accessories other than those specified may result in increased emissions or decreased immunity of the ultrasound system.

9-14 Safety Table 9-30: Accessories and peripherals compatible with SonoSite M-Turbo ultrasound system

Description Maximum Cable Length C8x transducera 6.0 ft / 1.8 m C11x transducera 6.0 ft/1.8 m C60x transducera 5.5 ft/1.7 m C60xi transducera,b 5.5 ft/1.7 m D2x transducera 5.5 ft/1.7 m HFL38x transducera 5.5 ft/1.7 m HFL50x transducera 5.7 ft/1.7 m ICTx transducera 5.5 ft/1.7 m L25x transducera 7.5 ft/2.3 m L38xi transducera 5.5 ft/1.7 m L52xa 7.9 ft/2.4 m P10x transducera 6.0 ft/1.8 m P21x transducera 6.5 ft/2.0 m SLAx transducera 8.0 ft/2.4 m TEExi transducera 11.8 ft/3.6 m Bar code scanner 4.8 ft/1.5 m Battery for PowerPack — Battery Pack — Battery PowerPack — Black & white printer — Black & white printer cable 3.3 ft/1 m Black & white printer USB cable 10.8 ft/3.3 m Color printer — Color printer power cable 3.3 ft/1 m Color printer video cable 6.0 ft/ 1.8 m ECG lead wires 24 in/ 0.6 m ECG module 5.8 ft/1.8 m Footswitch 9.8 ft/3.0 m H-Universal Stand — M-Turbo Dock — Petite mouse 6 ft /1.8 m Power cord (system) 10 ft/3 m Power supply with DC cable 6.8 ft/ 2 m

Safety 9-15 Table 9-30: Accessories and peripherals compatible with SonoSite M-Turbo ultrasound system Power supply AC cable 39 in/ 1 m PowerPark — Triple Transducer Connect — USB keyboard — USB wireless adapter — a For transducers, the maximum cable length is measured between the strain reliefs. The stated length do not include the lengths of cable in the following locations: underneath the strain reliefs, inside the transducer enclosure, and inside the transducer connector. b This transducer supports a multi-angle biopsy guide.

Guidance and manufacturer’s declaration

WARNING Other equipment, even equipment that complies with CISPR emission requirements, can interfere with the SonoSite M-Turbo ultrasound system.

The SonoSite M-Turbo ultrasound system contains an IEEE 802.11 receiver and transmitter that utilizes the ISM frequency band from 2.412 to 2.4835 GHz and implements three methods of transmission:

IEEE 802.11b with Complementary Code Keying (CCK), Differential Quaternary Phase Shift Keying (DQPSK), and Differential Binary Phase Shift Keying (DBPSK) at 17 dBm IEEE 802.11g with Orthogonal Frequency Division Multiplexing (OFDM) at 14 dBm IEEE 802.11n with OFDM at 14 dBm

Manufacturer’s declaration

The SonoSite M-Turbo ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the SonoSite M-Turbo ultrasound system should assure that it is used in such an environment.

Table 9-31: Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions test Compliance Electromagnetic environment

RF emissions Group 1 The SonoSite M-Turbo ultrasound ClSPR 11 system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

9-16 Safety Table 9-31: Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions test Compliance Electromagnetic environment

RF emissions Class A The SonoSite M-Turbo ultrasound ClSPR 11 system is suitable for use in all establishments other than Harmonic emissions Class A domestic and those directly IEC 61000-3-2 connected to the public Voltage fluctuations/flicker Complies low-voltage power supply network emissions which supplies buildings used for IEC 61000-3-3 domestic purposes.

Table 9-32: Guidance and manufacturer’s declaration - electromagnetic environment

Immunity test IEC 60601 test level Compliance level Electromagnetic environment Electrostatic ± 2.0KV, ± 4.0KV, ± 2.0KV, ± 4.0KV, Floors should be wood, concrete, discharge (ESD) ± 6.0KV contact ± 6.0KV contact or ceramic tile. If floors are covered IEC 61000-4-2 ± 2.0KV, ± 4.0KV, ± 2.0KV, ± 4.0KV, with synthetic material, the relative ± 8.0KV air ± 8.0KV air humidity should be at least 30%. Electrical fast ±2KV for power supply ±2KV for power Mains power quality should be Transient burst lines supply lines that of a typical commercial or IEC 61000-4-4 ±1KV for input/output ±1KV for input/output hospital environment. lines lines Surge ±1KV line(s) to line(s) ±1KV line(s) to line(s) Mains power quality should be IEC 61000-4-5 ±2KV line(s) to earth ±2KV line(s) to earth that of a typical commercial or hospital environment.

Voltage dips, short <5% UT <5% UT Mains power quality should be interruptions and (>95% dip in UT) for 0.5 (>95% dip in UT) for that of a typical commercial or voltage variations cycle 0.5 cycle hospital environment. If the user of the SonoSite M-Turbo ultrasound on power supply 40% UT 40% UT input lines system requires continued (60% dip in UT) for 5 (60% dip in UT) for IEC 61000-4-11 operation during power mains cycles 5cycles interruptions, it is recommended 70% UT 70% UT that the Sonosite M-Turbo (30% dip in UT) for 25 (30% dip in UT) for ultrasound system be powered cycles 25 cycles from an uninterruptible power <5% UT <5% UT supply or a battery. (>95% dip in UT) for 5s (>95% dip in UT) for 5s Power frequency 3 A/m 3 A/m Power frequency magnetic fields magnetic field should be at levels characteristic of IEC 61000-4-8 a typical location in a typical commercial or hospital environment.

Safety 9-17 Table 9-32: Guidance and manufacturer’s declaration - electromagnetic environment

Immunity test IEC 60601 test level Compliance level Electromagnetic environment Conducted RF 3Vrms 3Vrms Portable and mobile RF IEC 61000-4-6 150 kHz to 80 MHz communications equipment should be used no closer to any part of the SonoSite M-Turbo ultrasound system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distance d = 1.2 P Radiated RF 3Vim 3 V/m d = 1.2 P IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic Site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

aField strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FUJIFILM SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the FUJIFILM SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the FUJIFILM SonoSite ultrasound system. bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

9-18 Safety Note UT is the AC mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation.

Immunity testing requirements

The SonoSite M-Turbo ultrasound system complies with the essential performance requirements specified in IEC 60601-1-2 and IEC 60601-2-37:2008+A1:2015. Results of immunity testing show that the SonoSite M-Turbo ultrasound system meets these requirements and is free from the following:

Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that cannot be attributed to a physiological effect and that may alter the diagnosis Display of incorrect numerical values associated with the diagnosis to be performed Display of incorrect safety related indications Production of unintended or excessive ultrasound output Production of unintended or excessive transducer assembly surface temperature Production of unintended or uncontrolled motion of transducer assemblies intended for intracorporeal use

ALARA principle

ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other qualified ultrasound users, using good judgment and insight, determine the exposure that is “as low as reasonably achievable.” There are no set rules to determine the correct exposure for every situation. The qualified ultrasound user determines the most appropriate way to keep exposure low and bioeffects to a minimum, while obtaining a diagnostic examination.

A thorough knowledge of the imaging modes, transducer capability, system setup and scanning technique is necessary. The imaging mode determines the nature of the ultrasound beam. A stationary beam results in a more concentrated exposure than a scanned beam, which spreads that exposure over that area. The

Safety 9-19 transducer capability depends upon the frequency, penetration, resolution, and field of view. The default system presets are reset at the start of each new patient. It is the scanning technique of the qualified ultrasound user along with patient variability that determines the system settings throughout the exam.

The variables which affect the way the qualified ultrasound user implements the ALARA principle include: patient body size, location of the bone relative to the focal point, attenuation in the body, and ultrasound exposure time. Exposure time is an especially useful variable, because the qualified ultrasound user can control it. The ability to limit the exposure over time supports the ALARA principle.

Applying ALARA

The system imaging mode selected by the qualified ultrasound user is determined by the diagnostic information required. 2D imaging provides anatomical information; CPD imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used for detecting the presence of blood flow; Color imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used for detecting the presence, velocity, and direction of blood flow; tissue harmonic imaging uses higher received frequencies to reduce clutter, artifact, and improve resolution on the 2D image. Understanding the nature of the imaging mode used allows the qualified ultrasound user to apply the ALARA principle.

Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest ultrasound output for the shortest time necessary to achieve acceptable diagnostic results. Decisions that support prudent use are based on the type of patient, exam type, patient history, ease or difficulty of obtaining diagnostically useful information, and potential localized heating of the patient due to transducer surface temperature.

The system has been designed to ensure that temperature at the face of the transducer will not exceed the limits established in Section 42 of EN 60601-2-37:2008+A1:2015: Particular requirement for the safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer surface temperature rise” on page 9-26. In the event of a device malfunction, there are redundant controls that limit transducer power. This is accomplished by an electrical design that limits both power supply current and voltage to the transducer.

The sonographer uses the system controls to adjust image quality and limit ultrasound output. The system controls are divided into three categories relative to output: controls that directly affect output, controls that indirectly affect output, and receiver controls.

Direct controls

The system does not exceed a spatial peak temporal average intensity (ISPTA) of 720 mW/cm2 for all imaging modes. (For either the Ophthalmic or Orbital exam, the acoustic output is limited to the following values: ISPTA does not exceed 50 mW/cm2; TI does not exceed 1.0, and MI does not exceed 0.23.) The mechanical index (MI) and thermal index (TI) may exceed values greater than 1.0 on some transducers in some imaging modes. One may monitor the MI and TI values and adjust the controls to reduce these values.

9-20 Safety See “Guidelines for reducing MI and TI” on page 9-22. Additionally, one means for meeting the ALARA principle is to set the MI or TI values to a low index value and then modifying this level until a satisfactory image or Doppler mode is obtained. For more information on MI and TI, see BS EN 60601-2-37:2008+A1:2015: Annex HH.

Indirect controls

The controls that indirectly affect output are controls affecting imaging mode, freeze, and depth. The imaging mode determines the nature of the ultrasound beam. Tissue attenuation is directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the more output pulses occur over a period of time.

Receiver controls

The receiver controls are the gain controls. Receiver controls do not affect output. They should be used, if possible, to improve image quality before using controls that directly or indirectly affect output.

Acoustic artifacts

An acoustic artifact is information, present or absent in an image, that does not properly indicate the structure or flow being imaged. There are helpful artifacts that aid in diagnosis and those that hinder proper interpretation. Examples of artifacts include:

Shadowing Through transmission Aliasing Reverberations Comet tails

For more information on detecting and interpreting acoustic artifacts, see the following reference:

Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005).

Safety 9-21 Guidelines for reducing MI and TI

The following are general guidelines for reducing MI or TI. If multiple parameters are given, the best results may be achieved by minimizing these parameters simultaneously. In some modes changing these parameters does not affect MI or TI. Changes to other parameters may also result in MI and TI reductions. Please note the MI and TI values on the right side of the screen.

Table 9-33: MI

Transducer Depth C8x  C11x  C60x  C60xi  HFL38x  HFL50x  ICTx  L25x  L38x  L38xi  P10x  P21x  SLAx  TEEx  TEExi   Decrease or lower setting of parameter to reduce MI.  Increase or raise setting of parameter to reduce MI. Table 9-34: TI (TIS, TIC, TIB)

Color Power Doppler settings Transducer Box Box Box PW settings PRF Depth Optimize width height depth C8x  — — —  —  (Depth) C11x — —    —  (Depth) C60x  —    — (PRF) C60xi  —    — (PRF) HFL38x — —    — (Depth) HFL50x — —    — (Depth) ICTx —    — Exam Gyn  (PRF) L25x  — — —  —  (PRF) L38x — — —  — — (Depth)

9-22 Safety Table 9-34: TI (TIS, TIC, TIB)

Color Power Doppler settings Transducer Box Box Box PW settings PRF Depth Optimize width height depth L38xi   — — — — (Sample volume zone or size) P10x — —   — —  (PRF) P21x —  —   —  (PRF) SLAx — —    —  (PRF) TEEx — — —   —  (PRF) TEExi — — —   —  (PRF)  Decrease or lower setting of parameter to reduce TI.  Increase or raise setting of parameter to reduce TI.

Output display

The system meets the AIUM output display standard for MI and TI (see last reference in Related guidance documents below). Table 9-35 indicates for each transducer and operating mode when either the TI or MI is greater than or equal to a value of 1.0, thus requiring display.

Note The D2x transducer has a static continuous wave (CW) output. This output is fixed. Therefore, TI and MI values cannot be changed by any system controls available to the user.

Table 9-35: Modes in which a TI or MI  1.0 2D/ CPD/ Transducer model Index PW Doppler CW Doppler MMode Color C8x MI Yes Yes Yes — TIC,TIB, or TIS No No Yes — C11x/8-5 MI No No No — TIC,TIB, or TIS No Yes Yes — C60x/5-2 MI Yes No No — TIC, TIB, or TIS No No Yes — C60xi/5-2 MI Yes No No — TIC, TIB, or TIS No No Yes — D2x/2 MI — — — No TIC, TIB, or TIS — — — Yes

Safety 9-23 Table 9-35: Modes in which a TI or MI  1.0 (continued) 2D/ CPD/ Transducer model Index PW Doppler CW Doppler MMode Color HFL38x/13-6 MI Yes Yes Yes — TIC, TIB, or TIS No Yes Yes — HFL50x/15-6 MI Yes Yes Yes — TIC, TIB, or TIS No No Yes — ICTx/8-5 MI No No No — TIC, TIB, or TIS No No Yes — L25x/13-6 MI Yes No No — TIC,TIB, or TIS No No Yes — L38x/10-5 MI No Yes Yes — TIC, TIB, or TIS No Yes Yes — L38xi/10-5 MI Yes Yes Yes — TIC, TIB, or TIS No Yes Yes — P10x/8-4 MI No Yes Yes No TIC, TIB, or TIS Yes Yes Yes Yes P21x/5-1 MI Yes Yes Yes No TIC, TIB, or TIS Yes Yes Yes Yes SLAx/13-6 MI No No No — TIC, TIB, or TIS No No Yes — TEEx/8-3 MI No No No No TIC, TIB, or TIS No No Yes Yes TEExi/8-3 MI No No No No TIC, TIB, or TIS No No Yes Yes

Even when MI is less than 1.0, the system provides a continuous real-time display of MI in all imaging modes, in increments of 0.1.

The system meets the output display standard for TI and provides a continuous real-time display of TI in all imaging modes, in increments of 0.1.

The TI consists of three user-selectable indices, and only one of these is displayed at any one time. In order to display TI properly and meet the ALARA principle, the user selects an appropriate TI based on the specific exam being performed. FUJIFILM SonoSite provides a copy of AIUM Medical Ultrasound Safety, which contains guidance on determining which TI is appropriate (See “Related guidance documents” on page 9-25).

9-24 Safety MI and TI output display accuracy

The accuracy result for the MI is stated statistically. With 95% confidence, 95% of the measured MI values will be within +18% to -25% of the displayed MI value, or +0.2 of the displayed value, whichever value is larger.

The accuracy result for the TI is stated statistically. With 95% confidence, 95% of the measured TI values will be within +21% to -40% of the displayed TI value, or +0.2 of the displayed value, whichever value is larger. The values equate to +1dB to -3dB.

A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than 0.05.

Factors that contribute to display uncertainty

The net uncertainty of the displayed indices is derived by combining the quantified uncertainty from three sources: measurement uncertainty, system and transducer variability, and engineering assumptions and approximations made when calculating the display values.

Measurement errors of the acoustic parameters when taking the reference data are the major source of error that contributes to the display uncertainty. The measurement error is described in “Acoustic measurement precision and uncertainty” on page 9-74.

The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single reference transducer that is representative of the population of transducers of that type. The reference system and transducer are chosen from a sample population of systems and transducers taken from early production units, and they are selected based on having an acoustic output that is representative of the nominal expected acoustic output for all transducer/system combinations that might occur. Of course every transducer/system combination has its own unique characteristic acoustic output, and will not match the nominal output on which the display estimates are based. This variability between systems and transducers introduces an error into displayed value. By doing acoustic output sampling testing during production, the amount of error introduced by the variability is bounded. The sampling testing ensures that the acoustic output of transducers and systems being manufactured stays within a specified range of the nominal acoustic output.

Another source of error arises from the assumptions and approximations that are made when deriving the estimates for the display indices. Chief among these assumptions is that the acoustic output, and thus the derived display indices, are linearly correlated with the transmit drive voltage of the transducer. Generally, this assumption is very good, but it is not exact, and thus some error in the display can be attributed to the assumption of voltage linearity.

Related guidance documents

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 2008.

Safety 9-25 Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 2014. (A copy is included with each system.)

Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004.

Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993.

Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, NEMA UD3-2004.

Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH, BS EN 60601-2-37 reprinted at P05699.

Transducer surface temperature rise

Table 9-36 and Table 9-37 list the measured surface temperature rise from ambient (23°C ± 3°C) of transducers used on the ultrasound system. The temperatures were measured in accordance with EN 60601-2-37 section 42 with controls and settings positioned to give maximum temperatures.

For information about surface temperature rise for the TEExi transducer, refer to the TEExi Transducer User Guide, included with the TEExi transducer.

Table 9-36: Transducer surface temperature rise, external use (°C)

Test C11x C60x C60xi D2 HFL38x HFL50x L25x L38x Still air 14.3 16.2 14.8 8.3 12.8 11.3 14.5 16.3 Simulated 7.1 8.2 7.6 1.9 8.2 6.9 8.6 9.6 use Test L38xi P10x P21x Still air 13 16.1 17.2 Simulated 8.3 8.9 8.5 use Table 9-37: Transducer surface temperature rise, internal use (°C)

Test C8x ICTx SLAx TEEx TEExi Still air 9.2 8.3 9.5 9.3 8.6 Simulated 4.4 4.7 4.8 5.8 4.7 Use

9-26 Safety Acoustic output measurement

Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects) from ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report from its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement). The report, sometimes referred to as the Stowe Report, reviewed available data on possible effects of ultrasound exposure. Another report, “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993, provides more current information.

The acoustic output for this ultrasound system has been measured and calculated in accordance with “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD2-2004), and “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA UDe3-2004).

In Situ, derated, and water value intensities

All intensity parameters are measured in water. Since water does not absorb acoustic energy, these water measurements represent a worst case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount, type of tissue, and the frequency of the ultrasound passing through the tissue. The intensity value in the tissue, In Situ, has been estimated by using the following formula:

In Situ= Water [e-(0.23alf)] where:

In Situ = In Situ intensity value Water = Water intensity value e = 2.7183 a = attenuation factor (dB/cm MHz)

Safety 9-27 Attenuation factor (a) for various tissue types are given below:

brain = 0.53 heart = 0.66 kidney = 0.79 liver = 0.43 muscle = 0.55 l = skinline to measurement depth in cm f = center frequency of the transducer/system/mode combination in MHz

Since the ultrasonic path during the exam is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for general reporting purposes; therefore, the In Situ value commonly reported uses the formula:

In Situ (derated) = Water [e -(0.069lf)]

Since this value is not the true In Situ intensity, the term “derated” is used to qualify it.

The maximum derated and the maximum water values do not always occur at the same operating conditions; therefore, the reported maximum water and derated values may not be related by the In Situ (derated) formula. For example: a multi-zone array transducer that has maximum water value intensities in its deepest zone, but also has the smallest derating factor in that zone. The same transducer may have its largest derated intensity in one of its shallowest focal zones.

Tissue models and equipment survey

Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from measurements of acoustic output made in water. Currently, available models may be limited in their accuracy because of varying tissue paths during diagnostic ultrasound exposures and uncertainties in the acoustic properties of soft tissues. No single tissue model is adequate for predicting exposures in all situations from measurements made in water, and continued improvement and verification of these models is necessary for making exposure assessments for specific exam types.

A homogeneous tissue model with attenuation coefficient of 0.3 dB/cm MHz throughout the beam path is commonly used when estimating exposure levels. The model is conservative in that it overestimates the In Situ acoustic exposure when the path between the transducer and site of interest is composed entirely of soft tissue. When the path contains significant amounts of fluid, as in many first and second-trimester pregnancies scanned transabdominally, this model may underestimate the In Situ acoustic exposure. The amount of underestimation depends upon each specific situation.

9-28 Safety Fixed-path tissue models, in which soft tissue thickness is held constant, sometimes are used to estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely of fluid. When this model is used to estimate maximum exposure to the fetus during transabdominal scans, a value of 1 dB/ cm MHz may be used during all trimesters.

Existing tissue models that are based on linear propagation may underestimate acoustic exposures when significant saturation due to non-linear distortion of beams in water is present during the output measurement.

The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad range of values:

A survey of 1990-equipment models yielded MI values between 0.1 and 1.0 at their highest output settings. Maximum MI values of approximately 2.0 are known to occur for currently available equipment. Maximum MI values are similar for real-time 2D and M Mode imaging. Computed estimates of upper limits to temperature elevations during transabdominal scans were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. The vast majority of models yielded upper limits less than 1° and 4°C (1.8° and 7.2°F) for exposures of first-trimester fetal tissue and second-trimester fetal bone, respectively. The largest values obtained were approximately 1.5°C (2.7°F) for first-trimester fetal tissue and 7°C (12.6°F) for second-trimester fetal bone. Estimated maximum temperature elevations given here are for a “fixed path” tissue model and are for devices having ISPTA values greater than 500 mW/cm2. The temperature elevations for fetal bone and tissue were computed based on calculation procedures given in Sections 4.3.2.1-4.3.2.6 in “Bioeffects and Safety of Diagnostic Ultrasound” (AIUM, 1993).

Acoustic output tables

Table 9-38 through Table 9-80 indicate the acoustic output for the system and transducer combinations with a TI or MI equal to or greater than one. These tables are organized by transducer model and imaging mode. For a definition of terms used in the tables, see “Terms used in the acoustic output tables” on page 9-73.

For acoustic output tables for the TEExi transducer, refer to the TEExi Transducer User Guide, included with the TEExi transducer.

Safety 9-29 Table 9-38: Transducer model: C8x Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.1 (a) — — — (b)

pr.3 (MPa) 2.48 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.2 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 5.53 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.239 PRF (Hz) 9524

pr@PIImax (MPa) 3.11 deq@Pllmax (cm) —

Other Focal Length FLx (cm) # — — # information FLy (cm) # — — # IPA.3@MImax (W/cm2) 264 Control 1: Exam Type Pro — — — — — Control 2: Optimization Pen — — — — — Control 3: Depth 2.5 - — — — — —

control control 3.2 Operating conditions Control 4: MB Off — — — — — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data is reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data is not applicable for this transducer/mode.

9-30 Safety Table 9-39: Transducer model: C8x Operating mode: MMode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.4 — (a) — (a) (b)

pr.3 (MPa) 3.16 W0 (mW) — # # # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.1 # parameter deq(zsp) (cm) #

Associated acoustic fc (MHz) 5.07 — # — # # Dim of Aaprt X(cm) — # — # # Y(cm) — # — # # PD (μsec) 0.427 PRF (Hz) 800

pr@PIImax (MPa) 3.83 deq@Pllmax (cm) #

Other Focal Length FLx (cm) — # — # information FLy (cm) — # — # IPA.3@MImax (W/cm2) 482 Control 1: Exam Type Pro — — — — — Control 2: Optimization Pen — — — — —

control control Control 3: Depth 4.2 — — — — — Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data is reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data is not applicable for this transducer/mode.

Safety 9-31 Table 9-40: Transducer model: C8x Operating mode: Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.4 (a) — — — (b)

pr.3 (MPa) 3.18 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 0.8 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 4.82 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.694 PRF (Hz) 2548

pr@PIImax (MPa) 3.63 deq@Pllmax (cm) —

Other Focal Length FLx (cm) # — — # information FLy (cm) # — — # IPA.3@MImax (W/cm2) 555 Control 1: Exam Type Pro — — — — — Control 2: Mode CVD — — — — — Control 3: 2D Optimization/Depth Pen / — — — — — 1.5 - 1.9 Control 4: Color Optimization/PRF High / — — — — — Any conditions Control 5: Color Box Position/Size Short & — — — — — Operating control Operating control narrow / Any (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data is reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data is not applicable for this transducer/mode.

9-32 Safety .. Table 9-41: Transducer model: C8x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.2 — (a) — 2.0 (b)

pr.3 (MPa) 2.59 W0 (mW) — # 36.0 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.1 1.10 parameter deq(zsp) (cm) 0.28

Associated acoustic fc (MHz) 4.79 — # — 4.79 # Dim of Aaprt X(cm) — # — 1.12 # Y(cm) — # — 0.40 # PD (μsec) 1.131 PRF (Hz) 1008

pr@PIImax (MPa) 3.10 deq@Pllmax (cm) 0.28

Other Focal Length FLx (cm) — # — # information FLy (cm) — # — # IPA.3@MImax (W/cm2) 296 Control 1: Exam Type Pro — — — Pro — Control 2: Sample Volume Size 1 mm — — — 1 mm — Control 3: Sample Volume Position Zone 5 — — — Zone 5 — control control Operating conditions Control 4: PRF 1008 — — — 3125 — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data is reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data is not applicable for this transducer/mode.

Safety 9-33 Table 9-42: Transducer model: C11x Operating mode: CPD/Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) (a) — — — 1.0

pr.3 (MPa) # W0 (mW) # — — 38.8 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) # # — — — 4.37 Dim of Aaprt X(cm) # — — — 1.12 Y(cm) # — — — 0.50 PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) — Focal Length FLx (cm) # — — 4.29 FLy (cm) # — — 4.40 Other information IPA.3@MImax (W/cm2) # Control 1: Mode Any Control 2: Exam Type Abd Control 3: PRF 3676 Control 4: Optimization/Depth Low/ 5.1 control control Operating conditions Control 5: Color Box Position/Size Top/ Short & Narrow (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-34 Safety Table 9-43: Transducer model: C11x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — 1.0 — 1.7 1.8

pr.3 (MPa) # W0 (mW) — 46.0 24.9 25.4 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 1.06 parameter deq(zsp) (cm) 0.24

Associated acoustic fc (MHz) # — 4.36 — 4.37 4.36 Dim of Aaprt X(cm) — 1.76 — 0.28 0.20 Y(cm) — 0.50 — 0.50 0.50 PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.23 Focal Length FLx (cm) — 6.37 — 0.77 FLy (cm) — 4.40 — 4.40 Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Any Any Any Control 2: Sample Volume 2 mm 1 mm 1 mm Control 3: PRF 3906 10417 20833 control control Operating conditions Control 4: Sample Volume Position Zone 7 Zone 1 Zone 0 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-35 Table 9-44: Transducer model: C60x Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 (a) — — — (b)

pr.3 (MPa) 1.69 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 4.7 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 2.84 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.579 PRF (Hz) 5440

pr@PIImax (MPa) 2.679 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 197.7 Control 1: Exam Type Abd/ OB Control 2: Optimization Any Control 3: Depth 11/

control control 13 cm Operating conditions Control 4: THI On Control 5: MB (Multi Beam) On (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-36 Safety Table 9-45: Transducer model: C60x Operating mode: MMode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 — (a) — (a) (b)

pr.3 (MPa) 1.62 W0 (mW) — # # # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 4.7 # parameter deq(zsp) (cm) #

Associated acoustic fc (MHz) 2.85 — # — # # Dim of Aaprt X(cm) — # — # # Y(cm) — # — # # PD (μsec) 0.577 PRF (Hz) 800

pr@PIImax (MPa) 2.576 deq@Pllmax (cm) # Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) 184.3 Control 1: Exam Type Any Control 2: Optimization Pen Control 3: Depth 7.8 cm

control control Control 4: MB (Multi Beam) Off or Operating conditions On (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-37 Table 9-46: Transducer model: C60x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 3.1 (b)

pr.3 (MPa) # W0 (mW) — # 85.64 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 1.255 parameter deq(zsp) (cm) 0.51

Associated acoustic fc (MHz) # — # — 2.233 # Dim of Aaprt X(cm) — # — 0.6552 # Y(cm) — # — 1.3 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.415 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Abd Control 2: PRF Any Control 3: Sample Volume 12 mm control control Operating conditions Control 4: Sample Volume Position Zone 1 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-38 Safety Table 9-47: Transducer model: C60xi Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 (a) — — — (b)

pr.3 (MPa) 1.69 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 4.7 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 2.84 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.579 PRF (Hz) 5440

pr@PIImax (MPa) 2.679 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 197.7 Control 1: Exam Type Abd/ OB Control 2: Optimization Any Control 3: Depth 11/

control control 13 cm Operating conditions Control 4: THI On Control 5: MB (Multi Beam) On (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-39 Table 9-48: Transducer model: C60xi Operating mode: M Mode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 (a) — — (a) (b)

pr.3 (MPa) 1.62 W0 (mW) # — # # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 4.7 # parameter deq(zsp) (cm) #

Associated acoustic fc (MHz) 2.85 — # — # # Dim of Aaprt X(cm) — # — # # Y(cm) — # — # # PD (μsec) 0.577 PRF (Hz) 800

pr@PIImax (MPa) 2.576 deq@Pllmax (cm) # Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) 184.3 Control 1: Exam Type Any Control 2: Optimization Pen Control 3: Depth 7.8 cm

control control Control 4: MB Off or Operating conditions (Multi Beam) On (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-40 Safety Table 9-49: Transducer model: C60xi Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 3.1 (b)

pr.3 (MPa) # W0 (mW) — # 85.64 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 1.255 parameter deq(zsp) (cm) 0.51

Associated acoustic fc (MHz) # — # — 2.233 # Dim of Aaprt X(cm) — # — 0.6552 # Y(cm) — # — 1.3 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.415 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Abd Control 2: PRF Any Control 3: Sample 12 mm Volume control control Operating conditions Control 4: Sample Zone 1 Volume Position (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-41 Table 9-50: Transducer model: D2x Operating mode: CW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 2.6 (b)

pr.3 (MPa) # W0 (mW) — # 90.52 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 1.1 parameter deq(zsp) (cm) 0.66

Associated acoustic fc (MHz) # — # — 2.00 # Dim of Aaprt X(cm) — # — 0.8 # Y(cm) — # — 0.4 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.54 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Crd Control 2: Depth Fixed

control control Control 3: Zone Fixed Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode

9-42 Safety . Table 9-51: Transducer model: HFL38x/13-6 Operating mode: 2D

TIS TIB Index label MI Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.1 (a) — — — (b)

pr.3 (MPa) 2.56 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) —

parameter [email protected] 1.2

Associated acoustic deq(zsp) (cm) — fc (MHz) 5.33 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.525 PRF (Hz) 2450

pr@PIImax (MPa) 3.19 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # Other information FLy (cm) # — — # IPA.3@MImax (W/cm2) 325.3 Control 1: Exam Type Nrv/Bre/ — — — — — SmP/Msk Control 2: Optimization Any — — — — — control control Operating conditions Control 3: Depth 3.3 cm — — — — — Control 4: MBe On — — — — — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.)— Data are not applicable for this transducer/mode. — Data are not applicable for this transducer/mode.

Safety 9-43 Table 9-52: Transducer model: HFL38x Operating mode: CPD/Color

TIS TIB

Index label M.I. Non-scan Non- TIC Scan scan Aaprt1 Aaprt>1 Global maximum index value 1.1 1.0 — — — (b)

pr.3 (MPa) 2.556 W0 (mW) 37.69 — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.2 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 5.328 5.324 — — — # Dim of Aaprt X(cm) 0.44 — — — # Y(cm) 0.4 — — — # PD (μsec) 0.525 PRF (Hz) 2597

pr@PIImax (MPa) 3.187 deq@Pllmax (cm) — Focal Length FLx (cm) 1.32 — — # FLy (cm) 2.5 — — # Other information IPA.3@MImax (W/cm2) 325.5 Control 1: Mode Color Color — — — — Control 2: Exam Type Any Ven — — — — Control 3: Optimization/Depth/PRF Low/3.3 cm/ Med/ — — — — Any 2.7 cm/

control control 2841 Operating conditions Control 4: Color Box Position/Size Any Top/ — — — — Short (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode

9-44 Safety . Table 9-53: Transducer model: HFL38x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 — 1.1 — 2.0 (b)

pr.3 (MPa) 2.37 W0 (mW) — 43.01 43.01 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 0.9 1.1 parameter deq(zsp) (cm) 0.33

Associated acoustic fc (MHz) 5.32 — 5.30 — 5.30 # Dim of Aaprt X(cm) — 1.04 — 1.04 # Y(cm) — 0.4 — 0.4 # PD (μsec) 1.29 PRF (Hz) 1008

pr@PIImax (MPa) 2.404 deq@Pllmax (cm) 0.21 Focal Length FLx (cm) — 3.72 — # FLy (cm) — 2.5 — # Other information IPA.3@MImax (W/cm2) 323.35 Control 1: Exam Type Bre/Vas Any — Any — SmP/IMT Control 2: Sample Volume 1 mm 1mm — 1mm —

control control Control 3: PRF 1008 6250 — 6250 — Operating conditions Control 4: Sample Volume Position Zone 2 Zone 7 — Zone 7 — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode

Safety 9-45 Table 9-54: Transducer model: HFL50x Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.3 (a) — — — (b)

pr.3 (MPa) 3.051 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.2 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 5.36 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.5.21 PRF (Hz) 2733

pr@PIImax (MPa) 3.81 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 493 Control 1: Exam Type Any — — — — — Control 2: Optimization Any — — — — — Control 3: Depth 3.3 — — — — — control control Operating conditions Control 4: MB On — — — — — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-46 Safety Table 9-55: Transducer model: HFL50x Operating mode: M Mode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.2 — (a) — (a) (b)

pr.3 (MPa) 3.14 W0 (mW) — # # # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.4 # parameter deq(zsp) (cm) #

Associated acoustic fc (MHz) 6.75 — # — # # Dim of Aaprt X(cm) — # — # # Y(cm) — # — # # PD (μsec) 0.263 PRF (Hz) 1600

pr@PIImax (MPa) 4.35 deq@Pllmax (cm) # Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) 388 Control 1: Exam Type Any Control 2: Optimization Pen

control control Control 3: Depth 4.0 Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-47 Table 9-56: Transducer model: HFL50x Operating mode: CPD/Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.3 (a) — — — (b)

pr.3 (MPa) 3.05 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.2 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 5.36 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.521 PRF (Hz) 8233

pr@PIImax (MPa) 3.81 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 494 Control 1: Mode Any Control 2: Exam Type Any Control 3: Optimization/Depth Low/3.3 control control Operating conditions Control 4: PRF Any (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-48 Safety Table 9-57: Transducer model: HFL50x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.2 — 1.1 — 1.9 (b)

pr.3 (MPa) 2.69 W0 (mW) — 42.6 42.6 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.0 1.1 parameter deq(zsp) (cm) 0.33

Associated acoustic fc (MHz) 5.34 — 5.34 — 5.34 # Dim of Aaprt X(cm) — 1.08 — 1.08 # Y(cm) — 0.40 — 0.40 # PD (μsec) 1.29 PRF (Hz) 1008

pr@PIImax (MPa) 3.23 deq@Pllmax (cm) 0.22 Focal Length FLx (cm) — 3.72 — # FLy (cm) — 2.44 — # Other information IPA.3@MImax (W/cm2) 308 Control 1: Exam Type Any — Any — Any — Control 2: Sample Volume 1 mm — 1 mm — 1 mm — Control 3: PRF 1008 — 1563 - — 1563 - —

control control 3125 3125 Operating conditions Control 4: Sample Volume Position Zone 4 — Zone 8 — Zone 8 — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-49 Table 9-58: Transducer model: ICTx Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 1.2 (a)

pr.3 (MPa) # W0 (mW) — # 16.348 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 1.6 parameter deq(zsp) (cm) 0.192

Associated acoustic fc (MHz) # — # — 4.36 # Dim of Aaprt X(cm) — # — 0.6 # Y(cm) — # — 0.5 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.187 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Any Control 2: Sample Volume 3mm Control 3: PRF Any control control Operating conditions Control 4: Sample Volume Position Zone 1 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-50 Safety Table 9-59: Transducer model: L25x Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.2 (a) — — — (b)

pr.3 (MPa) 2.87 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 0.8 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 6.11 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.630 PRF (Hz) 1061

pr@PIImax (MPa) 3.39 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 478 Control 1: Exam Type Nrv/Msk/ — — — — — Ven/Vas Control 2: Optimization Any — — — — —

control control Control 3: Depth 1.9 - 2.2 — — — — — Operating conditions Control 4: MBe On — — — — — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) —Data are not applicable for this transducer/mode.

Safety 9-51 Table 9-60: Transducer model L25x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 1.7 (b)

pr.3 (MPa) # W0 (mW) — # 32.1 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 0.75 parameter deq(zsp) (cm) 0.30

Associated acoustic fc (MHz) # — # — 6.00 # Dim of Aaprt X(cm) — # — 0.76 # Y(cm) — # — 0.30 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.21 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type — — — — Vas/Ven/ — Nrv Control 2: Sample Volume — — — — 8 mm —

control control Control 3: PRF — — — — 1953 — Operating conditions Control 4: Sample Volume Position — — — — Zone 7 — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) —Data are not applicable for this transducer/mode.

9-52 Safety Table 9-61: Transducer model: L38x Operating mode: CPD/Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.3 1.0 — — — (b)

pr.3 (MPa) 2.89 W0 (mW) 64.88 — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.1 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 4.91 4.91 — — — # Dim of Aaprt X(cm) 0.54 — — — # Y(cm) 0.4 — — — # PD (μsec) 0.529 PRF (Hz) 9547

pr@PIImax (MPa) 3.48 deq@Pllmax (cm) — Focal Length FLx (cm) 1.5 — — # FLy (cm) 2.5 — — # Other information IPA.3@MImax (W/cm2) 439.3 Control 1: Mode Color CPD Control 2: Exam Type Any Bre Control 3: PRF 331 2137 Control 4: Optimization/Depth Any/3.1 Med/

control control 3.1 Operating conditions Control 5: Color Box Position/Size Any Def/ Def/Def (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) —Data are not applicable for this transducer/mode.

Safety 9-53 Table 9-62: Transducer model: L38x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.04 — 2.0 — 2.6 (b)

pr.3 (MPa) 2.345 W0 (mW) — 84.94 84.94 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 0.8 1.3 parameter deq(zsp) (cm) 0.4685

Associated acoustic fc (MHz) 5.01 — 5.05 — 5.05 # Dim of Aaprt X(cm) — 1.80 — 1.80 # Y(cm) — 0.4 — 0.4 # PD (μsec) 1.29 PRF (Hz) 1008

pr@PIImax (MPa) 2.693 deq@Pllmax (cm) 0.2533 Focal Length FLx (cm) — 5.54 — # FLy (cm) — 2.5 — # Other information IPA.3@MImax (W/cm2) 284.5 Control 1: Exam Type Any Vas Vas Control 2: Sample Volume 1mm 12 mm 12 mm Control 3: PRF 1008 Any Any

control control Control 4: Sample Volume Position Zone 0 Zone 7 Zone 7 Operating conditions (top) (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-54 Safety Table 9-63: Transducer model: L38xi/10-5 Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 (a) — — — (b)

pr.3 (MPa) 3.54 W0 (mW) # — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.0 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 5.76 # — — — # Dim of Aaprt X(cm) # — — — # Y(cm) # — — — # PD (μsec) 0.146 PRF (Hz) 7551

pr@PIImax (MPa) 4.32 deq@Pllmax (cm) — Focal Length FLx (cm) # — — # FLy (cm) # — — # Other information IPA.3@MImax (W/cm2) 776 Control 1: Exam Type Any — — — — — Control 2: Optimization Gen/Pen — — — — — Control 3: Depth 2.0 cm — — — — — control control Operating conditions Control 4: MB On/Off — — — — — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-55 Table 9-64: Transducer model: L38xi/10-5 Operating mode: M Mode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 — (a) — 1.2 (b)

pr.3 (MPa) 3.54 W0 (mW) — # 37.1 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.0 0.9 parameter deq(zsp) (cm) 0.49

Associated acoustic fc (MHz) 5.76 — # — 5.20 # Dim of Aaprt X(cm) — # — 1.86 # Y(cm) — # — 0.40 # PD (μsec) 0.146 PRF (Hz) 1600

pr@PIImax (MPa) 4.32 deq@Pllmax (cm) 0.49 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) 776 Control 1: Exam Type Any — — — Any — Control 2: Optimization Gen — — — Pen —

control control Control 3: Depth 4.7 cm — — — 7.3-9.0 cm — Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-56 Safety Table 9-65: Transducer model: L38xi/10-5 Operating mode: CPD/Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 1.1 — — — (b)

pr.3 (MPa) 3.30 W0 (mW) 47.5 — — # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 0.8 parameter deq(zsp) (cm)

Associated acoustic fc (MHz) 4.82 4.82 — — — # Dim of Aaprt X(cm) 0.66 — — — # Y(cm) 0.40 — — — # PD (μsec) 0.544 PRF (Hz) 2885

pr@PIImax (MPa) 3.79 deq@Pllmax (cm) — Focal Length FLx (cm) 1.86 — — # FLy (cm) 1.50 — — # Other information IPA.3@MImax (W/cm2) 605 Control 1: Mode CVD/ CVD — — — — CPD Control 2: Exam Type Any Bre — — — — Control 3: 2D Optimization/Depth Any/2.0- Any/3.8 — — — — 2.5 cm cm

control control Control 4: Color Optimization/PRF Any/Any Low/ — — — — Operating conditions 1323 Control 5: Color Box Position/Size Any/Any Any/ — — — — Default (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-57 Table 9-66: Transducer model: L38xi/10-5 Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.1 — 2.6 — 3.7 (b)

pr.3 (MPa) 2.56 W0 (mW) — 114.5 114.5 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 1.19 0.8 parameter deq(zsp) (cm) 0.49

Associated acoustic fc (MHz) 4.88 — 4.79 — 4.79 # Dim of Aaprt X(cm) — 1.86 — 1.86 # Y(cm) — 0.40 — 0.40 # PD (μsec) 1.22 PRF (Hz) 1008

pr@PIImax (MPa) 2.97 deq@Pllmax (cm) 0.45 Focal Length FLx (cm) — 5.54 — # FLy (cm) — 1.50 — # Other information IPA.3@MImax (W/cm2) 342 Control 1: Exam Type Bre/Vas — Bre/Vas — Bre/Vas — Control 2: Sample Volume 1 mm — 1 mm — 1 mm — Control 3: PRF 1008 — 10417 — 10417 — control control Operating conditions Control 4: Sample Volume Position Zone 1 — Zone 7 — Zone 7 — (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-58 Safety Table 9-67: Transducer model: P10x Operating mode: 2D Mode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) (a) — — — 1.0

pr.3 (MPa) # W0 (mW) # — — 35.24 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) # # — — — 4.84 Dim of Aaprt X(cm) # — — — 0.416 Y(cm) # — — — 0.7 PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) — Focal Length FLx (cm) # — — 1.67 FLy (cm) # — — 5.0 Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Neo Control 2: Optimization Gen Control 3: Depth 2.0 control control Operating conditions Control 4: MB/SonoHD Off/Off (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-59 Table 9-68: Transducer model: P10x Operating mode: Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 (a) — — — 1.3

pr.3 (MPa) 2.02 W0 (mW) # — — 41.38 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 2.4 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 3.90 # — — — 3.91 Dim of Aaprt X(cm) # — — — 0.608 Y(cm) # — — — 0.7 PD (μsec) 0.70 PRF (Hz) 2772

pr@PIImax (MPa) 2.80 deq@Pllmax (cm) — Focal Length FLx (cm) # — — 2.48 FLy (cm) # — — 5.0 Other information IPA.3@MImax (W/cm2) 252 Control 1: Mode Color Color Control 2: Exam Type Neo Abd Control 3: Optimization/Depth/PRF Low/ Med/ 3.7/ 2.0/

control control 772 2315 Operating conditions Control 4: Color Box Pos/Size Any/ Short/ Tall Narrow (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-60 Safety Table 9-69: Transducer model: P10x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.0 — 1.2 — 2.0 1.8

pr.3 (MPa) 2.03 W0 (mW) — 36.25 34.4 31.5 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 2.1 0.8 parameter deq(zsp) (cm) 0.32

Associated acoustic fc (MHz) 3.87 — 6.86 — 3.84 3.86 Dim of Aaprt X(cm) — 0.992 — 0.416 .224 Y(cm) — 0.7 — 0.7 0.7 PD (μsec) 1.28 PRF (Hz) 1563

pr@PIImax (MPa) 2.70 deq@Pllmax (cm) 0.25 Focal Length FLx (cm) — 6.74 — 0.92 FLy (cm) — 5.0 — 5.0 Other information IPA.3@MImax (W/cm2) 233 Control 1: Exam Type Crd Crd Neo Crd Control 2: Sample Volume 1 mm 7 mm 12 mm 1 mm Control 3: PRF/TDI 1563/ Any/ 15625/ 5208/

control control Off On Off Off Operating conditions Control 4: Sample Volume Position Zone 3 Zone 6 Zone 2 Zone 1 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-61 Table 9-70: Transducer model: P10x Operating mode: CW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — (a) — 2.1 2.0

pr.3 (MPa) # W0 (mW) — # 40.72 30.00 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 0.7 parameter deq(zsp) (cm) 0.36

Associated acoustic fc (MHz) # — # — 4.00 4.00 Dim of Aaprt X(cm) — # — 0.320 0.16 Y(cm) — # — 0.7 0.7 PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.27 Focal Length FLx (cm) — # — 0.92 FLy (cm) — # — 5.0 Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Card Card Control 2: Depth Any Any

control control Control 3: Zone Zone 3 Zone 0 Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-62 Safety Table 9-71: Transducer model: P21x Operating mode: 2D

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 (a) — — — 2.3

pr.3 (MPa) 2.03 W0 (mW) # — — 171.53 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 3.4 — parameter deq(zsp) (cm) —

Associated acoustic fc (MHz) 1.83 # — — — 1.94 Dim of Aaprt X(cm) # — — — 1.9 Y(cm) # — — — 1.3 PD (μsec) 1.03 PRF (Hz) 4444

pr@PIImax (MPa) 2.53 deq@Pllmax (cm) — Focal Length FLx (cm) # — — 18.46 FLy (cm) # — — 9.0 Other information IPA.3@MImax (W/cm2) 194 Control 1: Exam Type Card Card Control 2: Optimization Gen/ Pen Pen Control 3: Depth 4.7 cm 27 cm control control Operating conditions Control 4: THI On Off Control 5: Sector Width Any Narrow (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-63 Table 9-72: Transducer model: P21x Operating mode: MMode

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 — (a) — 1.4 1.1

pr.3 (MPa) 2.10 W0 (mW) — # 40.08 29.71 min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) 3.645 4.9 parameter deq(zsp) (cm) 0.343

Associated acoustic fc (MHz) 1.93 — # — 1.93 1.94 Dim of Aaprt X(cm) — # — 1.835 1.9 Y(cm) — # — 1.3 1.3 PD (μsec) 0.904 PRF (Hz) 800

pr@PIImax (MPa) 2.679 deq@Pllmax (cm) 0.341 Focal Length FLx (cm) — # — 18.46 FLy (cm) — # — 5.5 Other information IPA.3@MImax (W/cm2) 237.4 Control 1: Exam Type Abd/ Abd/OB Abd/OB OB /Card Control 2: Optimization Any Gen/Res Pen Control 3: Depth 7.5 cm 10/13 cm 27 cm

control control Control 4: THI On On Off Operating conditions Control 5: MB On On or Off On or Off (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-64 Safety Table 9-73: Transducer model: P21x Operating mode: CPD/Color

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.5 1.3 — — — 2.5

pr.3 (MPa) 2.03 W0 (mW) 136.91 — — 116.5 min of (mW) — [W.3(z1),ITA.3(z1)] z1 (cm) — zbp (cm) — zsp (cm) 3.4 — parameter deq(zsp) (cm) — Associated acoustic fc (MHz) 1.83 2.16 — — — 2.17 Dim of Aaprt X(cm) 0.918 — — — 0.46 Y(cm) 1.3 — — — 1.30 PD (μsec) 1.032 PRF (Hz) 2038

pr@PIImax (MPa) 2.53 deq@Pllmax (cm) — Focal Length FLx (cm) 3.68 — — 1.55 FLy (cm) 9.00 — — 9.00 Other information IPA.3@MImax (W/cm2) 194 Control 1: Mode Color CPD Color/CPD Control 2: Exam Type Crd OB TCD Control 3: PRF/Depth Any/ 850/7.5 2016/ 4.7 4.7 control control Operating conditions Control 4: Color Optimization Any Med Low Control 5: THI On Off Off Control 6: Color Box Size Any Short and Short and Narrow Narrow (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-65 Table 9-74: Transducer model: P21x Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value 1.2 — — 1.3 4.0 2.8

pr.3 (MPa) 1.73 W0 (mW) — — 95.55 200.7 min of [W.3(z1),ITA.3(z1)] (mW) 124.4 z1 (cm) 3.1 zbp (cm) 2.8 zsp (cm) 5.0 0.6 parameter deq(zsp) (cm) 0.49

Associated acoustic fc (MHz) 2.15 — — 2.22 2.23 2.12 Dim of Aaprt X(cm) — — 1.97 0.459 1.97 Y(cm) — — 1.3 1.3 1.30 PD (μsec) 1.182 PRF (Hz) 1562

pr@PIImax (MPa) 2.50 deq@Pllmax (cm) 0.49 Focal Length FLx (cm) — — 13.84 18.46 FLy (cm) — — 9.0 9.00 Other information IPA.3@MImax (W/cm2) 216 Control 1: Exam Type Card Card TCD Card Control 2: Sample Volume 1mm 3mm 14mm 1mm Control 3: PRF 1563 3906 12500 3125 control control Operating conditions Control 4: Sample Volume Position Zone 2 Zone 4 Zone 0 Zone 5 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

9-66 Safety Table 9-75: Transducer model: P21x Operating mode: CW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global maximum index value (a) — — 1.0 3.5 3.0

pr.3 (MPa) # W0 (mW) — — 90.1 104.9 min of [W.3(z1),ITA.3(z1)] (mW) 104.9 z1 (cm) 1.20 zbp (cm) 1.31 zsp (cm) # 1.255 parameter deq(zsp) (cm) 0.49

Associated acoustic fc (MHz) # — — 2.00 2.00 2.00 Dim of Aaprt X(cm) — — 0.46 0.655 0.459 Y(cm) — — 1.30 1.30 1.30 PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.45 Focal Length FLx (cm) — — 1.55 1.55 FLy (cm) — — 9.00 9.00 Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Card Card Card Control 2: Zone Zone 0 Zone 1 Zone 0 control control Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) — Data are not applicable for this transducer/mode.

Safety 9-67 Table 9-76: Transducer Model: SLAx Operating Mode: PW Doppler

TIS TIB Index Label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global Maximum Index Value (a) — (a) — 1.3 (b)

pr.3 (MPa) # W0 (mW) — # 11.3 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 0.72 parameter deq(zsp) (cm) 0.15

Associated acoustic Associated fc (MHz) # — # — 6.00 # Dim of Aaprt X(cm) — # — 0.32 # Y(cm) — # — 0.30 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.14 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Vas, Nrv, Ven Control 2: Sample Volume 6 mm

control control Control 3: PRF 20833 Operating conditions Control 4: Sample Vol. Position Zone 2 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.

9-68 Safety Table 9-77: Transducer model: TEEx Operating mode: PW Doppler

TIS TIB Index Label M.I. Non-scan TIC Scan Non-scan Aaprt1 Aaprt>1 Global Maximum Index Value (a) — (a) — 1.7 (b)

pr.3 (MPa) # W0 (mW) — # 29.29 # min of [W.3(z1),ITA.3(z1)] (mW) — z1 (cm) — zbp (cm) — zsp (cm) # 0.6 parameter deq(zsp) (cm) 0.34

Associated acoustic fc (MHz) # — # — 3.84 # Dim of Aaprt X(cm) — # — 0.261 # Y(cm) — # — 0.9 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.34 Focal Length FLx (cm) — # — # FLy (cm) — # — # Other information IPA.3@MImax (W/cm2) # Control 1: Exam Type Crd Control 2: Sample Volume 1mm Control 3: PRF  2604 control control Operating conditions Control 4: Sample Volume Position Zone 1 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.

Safety 9-69 Table 9-78: Transducer model: TEEx Operating mode: CW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan

Aaprt≤1 Aaprt>1 Global maximum index value (a) — (a) — 1.2 (b)

pr.3 (MPa) # W0 (mW) — # 27.23 # min of (mW) — [W.3(z1),ITA.3(z1)] z1 (cm) —

acoustic zbp (cm) — zsp (cm) # 1.1

parameter deq(zsp) (cm) 0.39

Associated fc (MHz) # — # — 4.00 # Dim of Aaprt X(cm) — # — 0.435 # Y(cm) — # — 0.9 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) # deq@Pllmax (cm) 0.34 Focal Length FLx (cm) — # — # Other

information FLy (cm) — # — # IPA.3@MImax (W/cm2) # Control 1: Exam type Crd Control 2: Depth Any

control control Control 3: Zone Zone 3 Operating conditions (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.

9-70 Safety Table 9-79: Transducer model: TEExi Operating mode: PW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan

Aaprt≤1 Aaprt>1 Global maximum index value (a) - (a) - 1.4 (b)

pr.3 (MPa) #

W0 (mW) - # 35.8 # min of (mW) -

W.3(z1),ITA.3(z1)]

z1 (cm) -

zbp (cm) -

zsp (cm) 2.57

parameter [email protected] (cm) #

deq(zsp) (cm) 0.29 Associated acoustic Associated

fc (MHz) # - # - 3.81 #

Dim of Aaprt X(cm) - # - 0.90 # Y(cm) - # - 0.90 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) #

deq@Pllmax (cm) 0.28

Other Focal Length FLx (cm) - # - # information FLy (cm) - # - # 2 IPA.3@MImax (W/cm ) # Control 1: Exam type Card Control 2: Sample volume size 1mm Control 3: Sample volume position Zone 3 control control Operating conditions Control 4: PRF 2604 (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.

Safety 9-71 Table 9-80: Transducer model: TEExi Operating mode: CW Doppler

TIS TIB Index label M.I. Non-scan TIC Scan Non-scan

Aaprt≤1 Aaprt>1 Global maximum index value (a) - (a) - 1.7 (b)

pr.3 (MPa) #

W0 (mW) - # 34.4 #

min of W.3(z1),ITA.3(z1)] (mW) -

z1 (cm) -

zbp (cm) -

zsp (cm) 1.1

[email protected] (cm) # parameter

deq(zsp) (cm) 0.34 Associated acoustic Associated fc (MHz) # - # - 4.00 #

Dim of Aaprt X(cm) - # - 0.43 # Y(cm) - # - 0.90 # PD (μsec) # PRF (Hz) #

pr@PIImax (MPa) #

deq@Pllmax (cm) 0.34

Other Focal Length FLx (cm) - # - # information FLy (cm) - # - # 2 IPA.3@MImax (W/cm ) # Control 1: Exam type Card Control 2: Sample volume Zone 2 Control 3: control control Operating conditions Control 4: (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.

9-72 Safety Terms used in the acoustic output tables Table 9-81: Acoustic output terms and definitions

Term Definition 2 ISPTA.3 Derated spatial peak, temporal average intensity in units of milliwatts/cm . TI type Applicable thermal index for the transducer, imaging mode, and exam type. TI value Thermal index value for the transducer, imaging mode, and exam type. MI Mechanical index. Ipa.3@MImax Derated pulse average intensity at the maximum MI in units of W/cm2. TIS (Soft tissue thermal index) is a thermal index related to soft tissues. TIS scan is the soft tissue thermal index in an auto-scanning mode. TIS non-scan is the soft tissue thermal index in the non-autoscanning mode. TIB (Bone thermal index) is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIB non-scan is the bone thermal index in the non-autoscanning mode. TIC (Cranial bone thermal index) is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body. Aaprt Area of the active aperture measured in cm2.

Pr.3 Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI (Megapascals).

Wo Ultrasonic power, except for TISscan, in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts.

W.3(z1) Derated ultrasonic power at axial distance z1 in units of milliwatts. ISPTA.3(z1) Derated spatial-peak temporal-average intensity at axial distance z1 (milliwatts per square centimeter). z1 Axial distance corresponding to the location of maximum [min(W.3(z), ITA.3(z) x 1 cm2)], where z > zbp in centimeters. z bp 1.69 Aaprt in centimeters. zsp For MI, the axial distance at which pr.3 is measured. For TIB, the axial distance at which TIB is a global maximum (for example, zsp = zb.3) in centimeters. deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to 4   Wo  ITAz , where ITA(z) is the temporal-average intensity as a function of z in centimeters. fc Center frequency in MHz.

Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in centimeters. PD Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of MI.

Safety 9-73 Table 9-81: Acoustic output terms and definitions (continued)

Term Definition PRF Pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI in Hertz.

pr@PIImax Peak rarefactional pressure at the point where the free-field, spatial-peak pulse intensity integral is a maximum in Megapascals.

deq@PIImax Equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity integral is a maximum in centimeters. FL Focal length, or azimuthal (x) and elevational (y) lengths, if different measured in centimeters.

Acoustic measurement precision and uncertainty

All table entries have been obtained at the same operating conditions that give rise to the maximum index value in the first column of the table. Measurement precision and uncertainty for power, pressure, intensity, and other quantities that are used to derive the values in the acoustic output table are shown in the table below. In accordance with Section 6.4 of the Output Display Standard, the following measurement precision and uncertainty values are determined by making repeat measurements and stating the standard deviation as a percentage.

Table 9-82: Acoustic measurement precision and uncertainty

Quantity Precision (% of standard deviation) Uncertainty (95% confidence) Pr 1.9% +11.2%

Pr.3 1.9% +12.2% Wo 3.4% +10% fc 0.1% +4.7% PII 3.2% +12.5 to -16.8%

PII.3 3.2% +13.47 to -17.5%

9-74 Safety Labeling symbols

The following symbols are used on the products, packaging, and containers.

Table 9-83: Standards labeling symbols

Standards development Reference Symbol Title Description organization number Manufacturer ISO 15223-1:2016 5.1.1 Indicates the medical device Medical devices – symbols manufacturer, as EU to be used with medical directives 90/385/EEC, 93/ device labels, labelling, and 42/EEC and 98/79/EC information to be supplied – Part 1: General requirements Non-ionizing IEC 60601-1-2:2007 5.1.1 Indicates generally elevated, electromagnetic Medical Electrical potentially hazardous levels radiation Equipment Part 1-2: General of non-ionizing radiation, or requirements for basic to indicate equipment or safety and essential systems e.g., in the medical performance – collateral electrical area that include standard: electromagnetic RF transmitters or that compatibility intentionally apply RF electromagnetic energy for diagnosis or treatment European ISO 15223-1 5.1.2 Indicates the Authorized community Medical devices - symbols representative in the authorized to be used with medical European Community representative device labels, labelling and information to be supplied.

Serial number ISO 15223-1:2016 5.1.7 Indicates the manufacturer’s Medical devices – symbols serial number so that a to be used with medical specific medical device can device labels, labelling, and be identified information to be supplied – Part 1: General requirements Catalog number ISO 15223-1:2016 5.1.6 Indicates the manufacturer’s Medical devices – symbols catalog number so that the to be used with medical medical device can be device labels, labelling, and identified information to be supplied – Part 1: General requirements

Safety 9-75 Table 9-83: Standards labeling symbols (continued)

Standards development Reference Symbol Title Description organization number Caution ISO 15223-1:2016 5.4.4 Indicates the need for the Medical devices – symbols user to consult the to be used with medical instructions for use for device labels, labelling, and important cautionary information to be supplied – information such as Part 1: General requirements warnings and precautions, that cannot for a variety of reasons, be presented on the medical device itself Fragile handle ISO 15223-1:2016 5.3.1 Indicates a medical device with care Medical devices – symbols that can be broken or to be used with medical damaged if not handled device labels, labelling, and carefully information to be supplied – Part 1: General requirements Keep dry ISO 15223-1:2016 5.3.4 .Indicates a medical device Medical devices – symbols that needs to be protected to be used with medical from moisture device labels, labelling, and information to be supplied – Part 1: General requirements Temperature limit ISO 15223-1:2016 5.3.7 Indicates the temperature Medical devices – symbols limits to which the medical to be used with medical device can be safely device labels, labelling, and exposed information to be supplied – Part 1: General requirements Atmospheric ISO 15223-1:2016 5.3.9 Indicates the range of pressure Medical devices – symbols atmospheric pressure to limitations to be used with medical which the medical device device labels, labelling, and can be safely exposed information to be supplied – Part 1: General requirements Humidity ISO 15223-1:2016 5.3.8 Indicates the range of limitation Medical devices – symbols humidity to which the to be used with medical medical device can be safely device labels, labelling, and exposed information to be supplied – Part 1: General requirements

9-76 Safety Table 9-83: Standards labeling symbols (continued)

Standards development Reference Symbol Title Description organization number Degree of ingress IEC 60601-1 Medical D.3 Protected against the effects protection electrical equipment Part 1: of temporary immersion provided by General requirements for enclosure basic safety and essential performance Refer to IEC 60601-1 D.2-10 Follow instructions for use instruction Medical electrical equipment (used in accordance with manual/booklet Part 1: General requirements IEC 60601-1) for basic safety and essential performance Consult ISO 15223-1:2016 5.4.3 Indicates the need for the instructions for Medical devices – symbols user to consult the use to be used with medical instructions for use device labels, labelling, and information to be supplied – Part 1: General requirements Alternating ISO 7000 / IEC 60417 5032 Indicates on the rating plate, current Graphical symbols for use that the equipment is on equipment suitable for alternating current only, in order to identify appropriate terminals Equipment mass IEC 60601-1 7.2.21 Total equipment mass Medical electrical equipment including its safe working Part 1: General requirements load for basic safety and essential performance Dangerous ISO 7000 / IEC 60417 5036 Indicates hazards arising voltage Graphical symbols for use from dangerous voltage on equipment

Stacking limit by ISO 7000 / IEC 60417 2403 Indicates that the items are number Graphical symbols for use not to be vertically stacked on equipment higher than the specified number of items

Safety 9-77 Table 9-83: Standards labeling symbols (continued)

Standards development Reference Symbol Title Description organization number Caution hot ISO 7000 / IEC 60417 5041 Indicates that the marked Graphical symbols for use item can be hot and should on equipment not be touched without taking care Caution, static ISO 7000 / IEC 60417 6204 Identifies areas with magnetic field Graphical symbols for use potentially hazardous static hazard on equipment magnetic fields and forces in an installation Type BF applied IEC 60601-1 D.2-10 Identifies type BF applied parts Medical electrical equipment part complying with IEC Part 1: General requirements 60601-1 for basic safety and essential performance Defibrillation- IEC 60601-1 Medical D.1-27 Identifies a proof type CF electrical equipment Part 1: defibrillation-proof type CF applied part General requirements for applied part complying with basic safety and essential IEC 60601-1 performance Electrostatic IEC 60417:2002 5134 Indicates packages sensitive device Graphical Symbols For Use containing electrostatic On Equipment sensitive devices, or identifies a device or a connector that has not been tested for immunity to electrostatic discharge

9-78 Safety Table 9-84: FDA Recognition numbers for Table 9-83

FDA recognition Standards development organization (SDO) number 5-118 ISO 15223-1:2016 Medical devices – symbols to be used with medical device labels, labelling, and information to be supplied – Part 1: General requirements 5-103 ISO 7000:2014 Graphical symbols used on equipment 19-4 AAMI/ANSI ES60601-1:2005 Medical electrical equip. - Part 1: General requirements for basic safety and essential performance 19-2 AAMI/ANSI/IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance

Table 9-85: Other Symbols

Standards development Reference Symbol Title Description organization number CSA mark — — Indicates CSA mark for Canadian Standards Association. The “C” and “US” indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI/UL standards, for use in Canada and the U.S., respectively Corrugated — — Indicates shipping box is recycle made of corrugated cardboard and should be recycled accordingly — — — FCC-Tested to Federal Communications Commission requirements Device complies with relevant FCC regulations for electronic devices RESY – recycling — — Indicates paper recycle symbol

Safety 9-79 Table 9-85: Other Symbols CE Marking Council Directive 93/42/EEC Article 17 Indicates European Annex XII technical conformity and identification of notified body responsible for implementation of the procedures set out in Annexes II, IV, V, and VI. Regulatory AS/NZS3820 — C-Tick—Regulatory Compliance Mark Compliance Mark for (RCM) Australia and New Zealand device complies with relevant Australian and New Zealand regulations for electronic devices. Recycle: BS EN 50419:2016 — Indicates do not throw in Electronic Marking of electrical and trash Equipment electronic equipment in accordance with Article 11(2) of Directive 2002/96/ EC (WEEE). INMETRO safety — — Indicates Brazil - symbols accredited certification body by the National Institute of Metrology Standardization and Industrial Quality (INMETRO) Handle with care

Follow manufacturer’s instructions for disinfecting time Indicates disinfect transducer

9-80 Safety Specifications

This chapter contains system and accessory specifications and standards. The specifications for recommended peripherals are in the manufacturers’ instructions.

Dimensions

System Length: 11.8 in. (29.97 cm)

Width: 10.8 in. (27.43 cm)

Height: 3.1 in. (7.87 cm)

Weight: 8.5 lbs. (3.9 kg) with the C60xi transducer and battery installed

Display Length: 8.4 in. (21.34 cm)

Height: 6.3 in. (16 cm)

Diagonal: 10.4 in. (26.4 cm)

Supported transducers C8x/8-5 MHz (6 ft/1.8 m) C11x/8-5 MHz (6 ft/1.8 m) C60x/5-2 MHz (5.5 ft/1.7 m) C60xi/5-2 MHz (5.5 ft/1.7 m) D2x/2 MHz (5.5 ft/1.7 m) HFL38x/13-6 MHz (5.5 ft/1.7 m) HFL50x/15-6 MHz (5.5 ft/1.7 m)

CHAPTER 10 ICTx/8-5 MHz (5.7 ft/1.7 m) L25x/13-6 MHz (7.5 ft/2.3 m)

Specifications 10-1 L38x/10-5 MHz (5.5 ft/1.7 m) L38xi/10-5 MHz (5.5 ft/1.7 m) P10x/8-4 MHz (6 ft/1.8 m) P21x/5-1 MHz(6 ft/1.8 m) SLAx/13-6 MHz (7.5 ft/2.3 m) TEEx/8-3 MHz (11.8 ft./3.6 m) TEExi/8-3 MHz (11.8 ft./3.6 m)

Imaging modes 2D (256 gray shades) Color Power Doppler (CPD) (256 colors) Color Doppler (Color) (256 colors) MMode Pulsed Wave (PW) Doppler Continuous Wave (CW) Doppler Tissue Doppler Imaging (TDI) Tissue Harmonic Imaging (THI)

Image and clip storage

Internal storage: The number of images and clips you can save depends on imaging mode and file format.

Accessories

The following items are either included with or available for use on the ultrasound system:

Battery Biopsy Guide Carry case ECG cable (6 ft/1.8 m) Education keys Footswitch Mini-Dock Mobile docking system Power supply System AC power cord (10 ft/3.1 m) Triple Transducer Connect

10-2 Specifications Peripherals

See the manufacturer’s specifications for the following peripherals.

Medical grade Bar code scanner, USB Black-and-white printer Recommended sources for printer paper: Contact Sony at 800-686-7669 or www.sony.com/professional to order supplies or to find the local distributor. Color printer

Non-medical grade Kensington security cable USB storage device temperature and humidity limits.

Note The temperature, pressure, and humidity limits apply only to the ultrasound system, transducers, and battery.

Operating

System, battery, and transducer

10–40°C (50–104°F), 15–95% R.H.

700 to 1060hPa (0.7 to 1.05 ATM)

Shipping and storage

System and transducer

-35–65°C (-31–149°F), 15–95% R.H.

500 to 1060hPa (0.5 to 1.05 ATM)

Battery

-20–60°C (-4–140°F), 15–95% R.H. (For storage longer than 30 days, store at or below room temperature.)

500 to 1060hPa (0.5 to 1.05 ATM)

Specifications 10-3 Electrical

Power Supply Input: 100-240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC

Power Supply Output #1: 15 VDC, 5.0 A Max

Power Supply Output #2: 12 VDC, 2.3 A Max

Combined output not exceeding 75 watts.

Battery

The battery comprises six lithium-ion cells plus electronics, a temperature sensor, and battery contacts. Run time is up to two hours, depending on imaging mode and display brightness.

Standards

Electromechanical safety standards

Standard Description

ANSI/AAMI Medical electrical equipment, Part 1: General requirements for basic safety and ES60601-1:2005/(R) essential performance (Consolidated Edition 3.1) 2012, and A1:2012

CAN/CSA C22.2 No. Medical electrical equipment–Part 1: General Requirements for Basic Safety 60601-1:2014 and Essential Performance (Edition 3.1)

IEC 60601-1:2012 Medical electrical equipment–Part 1: General Requirements for Basic Safety (Edition 3.1) and Essential Performance

IEC 60601-2-37:2007 Medical Electrical Equipment–Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-1-6:2013 Medical Electrical Equipment part 1-6: General requirements for basic safety and essential performance–Collateral Standard: Usability

JIS T0601-1:2012 Japanese Industrial Standard, Medical electrical equipment - Part 1: General (3rd Edition) requirements for basic safety and essential performance

10-4 Specifications EMC standards classification

Standard Description

IEC 60601-1-2:2007 Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests.

CISPR 11:2009 Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement.

The Classification for the ultrasound system, stand, accessories, and peripherals when configured together is: Group 1, Class A.

Acoustic standards

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.

NEMA UD 3-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine.

Biocompatibility standards

AAMI/ANSI/ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing (2009).

Airborne equipment standards

RTCA DO-160E, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118.

DICOM standard

NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.

The system conforms to the DICOM standard as specified in the SonoSite Edge II DICOM Conformance Statement, available at www.sonosite.com. This statement provides information about the purpose, characteristics, configuration, and specifications of the network connections supported by the system.

Specifications 10-5 HIPAA

The system includes security settings that help you to meet the applicable security requirements listed in the HIPAA regulation listed below. Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected, stored, reviewed, and transmitted on the system.

The Health Insurance Portability and Accountability Act, Pub.L. No. 104-191 (1996), section 45 CFR 164.312, Security and Privacy.

10-6 Specifications IT Network

Functions

This device can be connected to an IT network to perform the following functions:

Storing the examination data (static images, clips) acquired by this device in a Picture Archiving and Communication System (PACS) by DICOM communication. Querying examination orders from the Modality Worklist (MWL) server by DICOM communication and starting them. Uploading images to the FUJIFILM SonoSite Patient Data Archival Software (PDAS) or SiteLink Image Manager. Setting the time of this device by interrogating the network time service. Communicating procedure status via the Modality Performed Procedure Step (MPPS) service. Requesting transfer of responsibility for image ownership to another system via the Storage Commitment service.

Network for connecting the device

To ensure safety, use an IT network that is isolated from the external environment by a firewall.

Specifications for the connection

Hardware specification 802.11 b/g/n Ethernet 100BASE-TX/10BASE-T using RJ45 port with patch cable

Software specifications This device is connected to PACS and MWL by the DICOM standard. Refer to the DICOM Conformance Statement of this device for details. When available, this device connects to the network time server at startup. CHAPTER 11

IT Network 11-1 The system conforms to the DICOM standard as specified in the SonoSite M-Turbo and S Series DICOM Conformance Statement, available at www.sonosite.com. This statement provides information about the purpose, characteristics, configuration, and specifications of the network connections supported by the system.

Security The port for DICOM communication (specified by the user in the system settings; typically port 104, 2762, or 11112) is used for outgoing communication to the network. Antivirus software is not installed on this device. This device has a single configurable listening port for the purposes of DICOM Echo and Storage Commitment.

Data flow

DICOM

MWL Server------> M-Turbo system------> PACS Study order Study data (DICOM MWL) (DICOM Storage)

Please refer to the Turbo DICOM Conformance Statement (D05690) for details.

Caution 1 Connection of equipment to an IT network that includes other systems, could result in previously unidentified risks to patients, operators or third parties. Before connecting the equipment to an uncontrolled IT Network, make sure that all potential risks resulting from such connections, were identified and evaluated, and suitable countermeasures were put in place. IEC 80001-1:2010 provides guidance for addressing these risks.

2 When a setting of the IT network to which this device is connected has been changed, check that the change does not affect this device and take measures if necessary. Changes to the IT network include:

Changes in network configuration (IP address, router etc.) Connection of additional items Disconnection of items Update of equipment Upgrade of equipment Any changes to the IT network could introduce new risks requiring additional evaluation to be performed as per item 1 above.

11-2 IT Network Glossary

Terms

For ultrasound terms not included in this glossary, refer to Recommended Ultrasound Terminology, Second Edition, published in 1997 by the American Institute of Ultrasound in Medicine (AIUM).

as low as reasonably The guiding principle of ultrasound use, which states that you should achievable (ALARA) keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results.

curved array Identified by the letter C (curved or curvilinear) and a number (60). transducer The number corresponds to the radius of curvature of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, C15, C60e.

depth Refers to the depth of the display. A constant speed of sound of 1538.5 meters/second is assumed in the calculation of echo position in the image.

in situ In the natural or original position.

LCD liquid crystal display

linear array Identified by the letter L (linear) and a number (38). The number transducer corresponds to the radius of width of the array expressed in millimeters. The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam. For example, L38.

mechanical index An indication of the likelihood of mechanical bioeffects occurring: the (MI) higher the MI, the greater the likelihood of mechanical bioeffects. See Chapter 9, “Safety,” for a more complete description of MI.

MI/TI See mechanical index (MI) and thermal index (TI).

NTSC National Television Standards Committee. A video format setting. See also PAL.

PAL Phase Alternating Line. A video format setting. See also NTSC.

phased array A transducer designed primarily for cardiac scanning. Forms a sector image by electronically steering the beam direction and focus.

skinline A depth on the display that corresponds to the skin/transducer interface.

Glossary A-1 SonoHD™ Imaging A subset of the 2D imaging mode in which the 2D image is enhanced Technology by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image.

SonoMBe A subset of the 2D imaging mode in which the 2D image is enhanced technology by looking at a target from multiple angles and then merging or averaging the scanned data together to improve overall image quality and, in parallel, reducing noise and artifacts.

Tissue Doppler A pulsed wave Doppler technique used to detect myocardial motion. Imaging (TDI)

thermal index (TI) The ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1°C under defined assumptions. See Chapter 9, “Safety,” for a more complete description of TI.

TIB (bone thermal A thermal index for applications in which the ultrasound beam passes index) through soft tissue and a focal region is in the immediate vicinity of bone.

TIC (cranial bone A thermal index for applications in which the ultrasound beam passes thermal index) through bone near the beam entrance into the body.

TIS (soft tissue A thermal index related to soft tissues. thermal index)

Tissue Harmonic Transmits at one frequency and receives at a higher harmonic Imaging frequency to reduce noise and clutter and improve resolution.

transducer A device that transforms one form of energy into another form of energy. Ultrasound transducers contain piezoelectric elements, which when excited electrically, emit acoustic energy. When the acoustic energy is transmitted into the body, it travels until it encounters an interface, or change in tissue properties. At the interface, an echo is formed that returns to the transducer, where this acoustic energy is transformed into electrical energy, processed, and displayed as anatomical information.

variance Displays a variation in Color Doppler flow imaging within a given sample. Variance is mapped to the color green and is used to detect turbulence.

A-2 Glossary Abbreviations Table A-86: Abbreviations in user interface

Abbreviation Definition

+/× “+” Caliper/”×” Caliper Ratio

A“A” Wave Peak Velocity

A PG “A” Wave Peak Pressure Gradient

A2Cd Apical 2 Chamber diastolic

A2Cs Apical 2 Chamber systolic

A4Cd Apical 4 Chamber diastolic

A4Cs Apical 4 Chamber systolic

AAA Abdominal Aortic Aneurysm

AAo Ascending Aorta

Abd Abdomen

abs Absolute value

AC Abdominal Circumference

ACA Anterior Cerebral Artery

ACC Acceleration Index

ACoA Anterior Communicating Artery

ACS Aortic Valve Cusp Separation

Adur “A” wave duration

AFI Amniotic Fluid Index

AI Aortic Insufficiency

AI PHT Aortic Insufficiency Pressure Half Time

AL Atlas Loop

Ann D Annulus Diameter

ANT F Anterior Far

ANT N Anterior Near

Glossary A-3 Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

Ao Aorta

AoD Aortic Root Diameter

Apical Apical View

APTD Anteroposterior Trunk Diameter

AT Acceleration (Deceleration) Time

AUA Average Ultrasound Age Calculated by averaging the individual ultrasound ages for the fetal biometry measurements performed during the exam. The measurements used to determine the AUA are based on the selected OB calculation authors.

AV Aortic Valve

AV Area Aortic Valve Area

AVA Aortic Valve Area

BA Basilar Artery

Bifur Bifurcation

BP Blood Pressure

BPD Biparietal Diameter

BPM Beats per Minute

Bre Breast

BSA Body Surface Area

CCA Common Carotid Artery

CI Cardiac Index

CM Cisterna Magna

CO Cardiac Output

CPD Color Power Doppler

Crd Cardiac

CRL Crown Rump Length

A-4 Glossary Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

CW Continuous Wave Doppler

CxLen Cervix Length

DDiameter

D Apical Distance Apical

DCCA Distal Common Carotid Artery

DECA Distal External Carotid Artery

DICA Distal Internal Carotid Artery

Dist Distal

dP:dT Delta Pressure: Delta Time

E “E” Wave Peak Velocity

E PG “E” Wave Peak Pressure Gradient

E:A E:A Ratio

E/e’ E velocity = Mitral Valve E velocity divided by the annular e’ velocity

ECA External Carotid Artery

ECG Electrocardiogram

ECICA Extracranial Internal Carotid Artery

ECVA Extracranial Vertebral Artery

EDD Estimated Date of Delivery

EDD by AUA Estimated Date of Delivery by Average Ultrasound Age The estimated date of delivery calculated from the measurements performed during the exam.

EDD by LMP Estimated Date of Delivery by Last Menstrual Period The due date calculated from the user-entered LMP.

EDV End Diastolic Velocity

EF Ejection Fraction

EF:SLOPE E-F Slope

Glossary A-5 Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

EFW Estimated Fetal Weight Calculated from the measurements performed during the exam. The measurements used to determine EFW are defined by the currently selected EFW calculation author.

Endo Endocardial

Epi Epicardial

EPSS “E” Point Septal Separation

Estab. DD Established Due Date A user-entered due date based on previous exam data or other available information. The LMP is derived from the Established Due Date and is listed in the patient report as LMPd.

ET Elapsed Time

FH Femoral Head

FHR Fetal Heart Rate

FL Femur Length

FM (Right and Left) Foramen Magnum (same as SO)

FTA Fetal Trunk Area

GA Gestational Age

GA by LMP Gestational Age by Last Menstrual Period The fetal age calculated using the date of the Last Menstrual Period (LMP).

GA by LMPd Gestational Age by derived Last Menstrual Period The fetal age calculated using the Last Menstrual Period (LMPd) derived from the Estab. DD.

Gate Depth of Doppler Gate

GS Gestational Sac

Gyn Gynecology

HC Head Circumference

HL Humerus Length

A-6 Glossary Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

HR Heart Rate

ICA Internal Carotid Artery

IMT Intima Media Thickness

IVRT Iso Volumic Relaxation Time

IVS Interventricular Septum

IVSd Interventricular Septum Diastolic

IVSFT Interventricular Septum Fractional Thickening

IVSs Interventricular Septum Systolic

LA Left Atrium

LA/Ao Left Atrium/Aorta Ratio

LAT F Lateral Far

LAT N Lateral Near

Lat V Lateral Ventricle

LMP Last Menstrual Period

LMP Last Menstrual Period The first day of the last menstrual period. Used to calculate gestational age and EDD.

LMPd derived Last Menstrual Period Calculated from the user-entered Estab. DD.

LV Left Ventricular

LV Area Left Ventricular Area

LV mass Left Ventricular mass

LV Volume Left Ventricular Volume

LVd Left Ventricular diastolic

LVD Left Ventricular Dimension

LVDd Left Ventricular Dimension Diastolic

LVDFS Left Ventricular Dimension Fractional Shortening

Glossary A-7 Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

LVDs Left Ventricular Dimension Systolic

LVEDV Left Ventricular End Diastolic Volume

LVESV Left Ventricular End Systolic Volume

LVET Left Ventricular Ejection Time

LVO Left Ventricular Opacification

LVOT Left Ventricular Outflow Tract

LVOT Area Left Ventricular Outflow Tract Area

LVOT D Left Ventricular Outflow Tract Diameter

LVOT VTI Left Ventricular Outflow Tract Velocity Time Integral

LVPW Left Ventricular Posterior Wall

LVPWd Left Ventricular Posterior Wall Diastolic

LVPWFT Left Ventricular Posterior Wall Fractional Thickening

LVPWs Left Ventricular Posterior Wall Systolic

LVs Left Ventricular systolic

MBe SonoMBe technology

MBe MultiBeam enhancement

MCA Middle Cerebral Artery

MCCA Mid Common Carotid Artery

MECA Mid External Carotid Artery

MI Mechanical Index

MICA Mid Internal Carotid Artery

Mid Middle

MM M Mode

MR PISA Mitral Regurgitation Proximal Iso Velocity Surface Area

MR/VTI Mitral Regurgitation/Velocity Time Integral

A-8 Glossary Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

Msk Musculoskeletal

MV Mitral Valve

MV Area Mitral Valve Area

MV Regurgitant Mitral Valve Regurgitant Fraction Fraction

MV Regurgitant Volume Mitral Valve Regurgitant Volume

MV/VTI Mitral Valve/Velocity Time Integral

MVA Mitral Valve Area

MV ERO Mitral Valve Effective Regurgitant Orifice

MV PISA Area Mitral Valve Proximal Iso Velocity Surface Area

MV Rate Mitral Valve Rate

Neo Neonatal

Nrv Nerve

NST Non-stress test

NTSC National Television Standards Committee

OA Ophthalmic Artery

OB Obstetrical

OFD Occipital Frontal Diameter

Oph Ophthalmic

Orb Orbital

PAL Phase Alternating Line

PCAp Posterior Cerebral Artery Peak

PCCA Proximal Common Carotid Artery

PCoA Posterior Communicating Artery

PECA Proximal External Carotid Artery

PGmax Maximum Pressure Gradient

Glossary A-9 Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

PGmean Mean Pressure Gradient

PGr Pressure Gradient

PHT Pressure Half Time

PI Pulsatility Index

PICA Proximal Internal Carotid Artery

PISA Proximal Isovelocity Surface Area

Plaq Plaque

POST F Posterior Far

POST N Posterior Near

PRF Pulse Repetition Frequency

Prox Proximal

PSV Peak Systolic Velocity

PV Pulmonic Valve

P. Vein Pulmonary Vein

PW Pulsed Wave Doppler

Qp/Qs Pulmonary blood flow divided by systemic blood flow

RA Right Atrial (pressure)

RI Resistive Index

RVD Right Ventricular Dimension

RVDd Right Ventricular Dimension Diastolic

RVDs Right Ventricular Dimension Systolic

RVOT D Right Ventricular Outflow Tract Diameter

RVOT VTI Right Ventricular Outflow Tract Velocity Time Integral

RVSP Right Ventricular Systolic Pressure

RVW Right Ventricular Free Wall

A-10 Glossary Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

RVWd Right Ventricular Free Wall Diastolic

RVWs Right Ventricular Free Wall Systolic

S SonoHD technology

S/D Systolic/Diastolic Ratio

SI Stroke Index

Siphon Siphon (internal carotid artery)

SM Submandibular

SmP Small Parts

SO Suboccipital

Sup Superficial

SV Stroke Volume

TAM Time Average Mean

TAP Time Average Peak

TCD Trans-cerebellum Diameter (OB measurement) Transcranial Doppler (exam type)

TDI Tissue Doppler Imaging

THI Tissue Harmonic Imaging

TI Thermal Index

TICA Terminal Internal Carotid Artery

TO Transorbital

TRmax Tricuspid Regurgitation (peak velocity)

TT Transtemporal

TTD Transverse Trunk Diameter

TV Tricuspid Valve

TVA Tricuspid Valve Area

Glossary A-11 Table A-86: Abbreviations in user interface (continued)

Abbreviation Definition

UA Ultrasound Age Calculated on the mean measurements taken for a particular fetal biometry.

Umb A Umbilical Artery

VA Vertebral Artery

VArty Vertebral Artery

Vas Vascular

Ven Venous

VF Volume Flow

Vmax Peak Velocity

Vmean Mean Velocity

Vol Volume

VTI Velocity Time Integral

YS Yolk Sac

A-12 Glossary Index setup 3-6 aorta (Ao) 5-22 aortic valve area (AVA) 5-26 +/x measurement 5-6 archivers 3-8 2D imaging 4-1 arrow graphic 4-18 2D options 4-2 ascending aorta (AAo) 5-22 A & B shortcut keys 3-1 audio 3-8 abbreviations A-3 bar code scanner 3-9 abdominal, intended uses 2-18 baseline 4-10 AC battery cord 2-5 clean 8-4 power 2-5 safety 9-8 AC power indicator 2-10 setup 3-8 acceleration (ACC) index 5-6 specifications 10-4 accessories beeps 3-8 compatible 9-14 biological safety 9-10 accessories list 10-2 bodymarker. See pictographs acoustic measurement precision 9-74 brightness 4-2 acoustic output cables. See cords measurement 9-27 calculations tables 9-29, 9-73 cardiac. See cardiac calculations acquisition error 6-3 delete measurement 5-9–5-10 add new user 3-3 general 5-8 Administrator 3-2 IMT 5-32 age, gestational 5-37 menu 2-11, 5-8 airborne equipment standards 10-5 OB 5-36 ALARA principle 9-19–9-20, A-1 percent area 5-12 alphanumeric keys 2-9 percent diameter 5-12 angle correction 4-8–4-9 percent reductions 5-11 annotations perform measurement 5-9 keys 2-9 performing 5-9 place 4-17 repeat measurement 5-9 predefine label groups 3-7 save 5-9

B-1 small parts 5-40 cardiac references 6-4 specialized 5-16 cardiac, intended uses 2-18 vascular 5-44 cautions, definition 1-2 view measurement 5-9 cine buffer 2-9, 4-11 volume 5-13 clean volume flow 5-14 battery 8-4 calipers 5-2 ECG cable 7-6, 7-10 cardiac calculations cleaning AAo 5-22 stand 7-12 Ao 5-22 clip acquisition delay 4-28 AVA 5-26 clips CI 5-28 See also images and clips CO 5-28–5-29 options 4-3, 4-23 dP:dT 5-26 color Doppler (Color) imaging 4-6 HR 5-28 color power Doppler (CPD) imaging 4-6 IVRT 5-20 color scheme, background 3-14 LA 5-22 color suppress 4-6 LV volume (Simpson’s Rule) 5-22 Color. See color Doppler (Color) imaging LVd 5-22 compatible LVOT D 5-22 accessories 9-14 LVs 5-22 peripherals 9-14 MV/AV area 5-22 connectivity setup, wireless certificates 3-8 overview 5-16, 8-1, 9-1 continuous wave (CW) Doppler imaging 4-7, 4-9 PHT 5-24 controls PISA 5-18 direct 9-20 RVSP 5-24 indirect 9-21 setup 3-8 receiver 9-21 SV 5-27 cords TDI 5-30 AC 2-5 VTI 5-24 DC 2-5 4-8 cardiac imaging applications CPD. See color power Doppler (CPD) imaging cardiac index (CI) 5-28 CW Doppler. See continuous wave (CW) Dop- cardiac output (CO) 5-28–5-29 pler imaging

B-2 date 3-9 safety 9-4 DC specifications 10-4 cord 2-5 electromagnetic default settings 3-1 emissions 9-16 delta pressure:delta time (dP:dT) 5-26 electromagnetic compatibility 9-11 depth electromechanical safety standards 10-4 adjust 4-10 EMC classification standards 10-5 definition A-1 EMED worksheets 5-48–5-49 keys 2-9 equipment safety 9-7 marker 2-11 error message 9-7 DICOM 3-8, 11-2 errors eFilm Lite 3-15 acquisition 6-3 disinfect algorithmic 6-3 battery 8-4 measurement 6-3 ECG cable 7-6, 7-10 estimated date of delivery (EDD) 6-12 display setup 3-9 estimated fetal weight (EFW) 6-13 distance measurements Event log 3-5 2D 5-3 exam Mmode 5-4 change type 4-14 D-line 4-8 end 4-20 Doppler type and transducer 4-14 Doppler gate depth 4-9 export and import measurements 5-5 OB calculation tables 3-11 scale setup 3-13 predefined label groups 3-7 dual images 4-2 user accounts 3-4 duplex 3-13 far 2-9 DVD recorder 3-9, 8-2 fetal heart rate (FHR) 5-39 Dynamic Range 3-13 flow sensitivity 4-7 ECG focal zones, optimize 4-2 Monitoring 4-3, 4-27 footswitch setup 3-1 eFilm Lite image-viewer 3-15 forms 2-10 elapsed time (ET) measurement 5-6 freeze 4-11 electrical gain

B-3 adjust 4-10 include private tags, private tags 3-15 ECG 4-28 infertility, intended uses 2-18 knob 2-9 intended uses 2-18–2-20 gate size 4-9 intensity gestational age derated 9-27 setup 3-10 in situ 9-27 tables, references 6-13 water-value 9-27 gestational growth, measure 5-38 interventional, intended uses 2-18 grace period 8-2 Intima Media Thickness (IMT) growth analysis calculations 3-10, 5-32 setup 3-10 sketch 5-35 tables, references 6-16 trace 5-35 guidance documents, related 9-25 intraoperative, intended uses 2-18 guideline 4-3 invert gynecology (Gyn) Color 4-7 intended uses 2-18 spectral trace 4-10 heart rate 4-21 iso volumic relaxation time (IVRT) 5-20 heart rate (HR) 5-5, 5-28, 5-39 keys 2-9 HIPAA standard 10-6 knobs 2-9 home position 4-18 labeling symbols 9-75 humidity limits 10-3 language 3-13 image quality, poor 8-1 layout 3-13 images and clips LCD screen archive 4-27 output 9-25 delete 4-27 left atrium (LA) 5-22 export to USB 4-26 left ventricular diastolic (LVd) 5-22 review 4-25 left ventricular outflow tract diameter (LVOT imaging modes D) 5-22 list of 10-2 left ventricular systolic (LVs) 5-22 transducer 4-14 left ventricular volume (LV volume) 5-22 import. See export and import license key 8-3 IMT. See Intima Media Thickness (IMT) live trace 3-13, 4-10 in situ, definition A-1 login

B-4 Administrator 3-2 mode data 2-11, 3-9 user 3-3 modes, keys 2-10 LVO (Left Ventricular Opacification) 4-2 MPPS 3-8 M Mode imaging 4-5 near 2-9 measurements network 3-10 +/x Ratio, Doppler 5-6 networking 11-1 2D 5-2 note, definition 1-2 Acceleration, Doppler 5-6 NTSC accuracy 5-2, 6-1 definition A-1 area, 2D 5-3 option 3-9 automatic trace, Doppler 5-7 OB circumference, 2D 5-3 calculations 3-10, 5-36 delete 5-2 custom measurements setup 3-11 distance, 2D 5-3 custom tables setup 3-12 distance, M Mode 5-4 graphs 5-48 Doppler 5-5 intended uses 2-19 edit 5-2 references 6-12 Elapsed Time, Doppler 5-6 tables setup 3-12 errors 6-3 on-screen controls 2-10 fetal heart rate 5-39 optimize 4-2 heart rate 5-5, 5-39 Orbital calculations 5-41 M Mode 5-4 orientation manual trace 5-4, 5-6 marker 2-11 Pressure Gradient, Doppler 5-5 option 4-2 publications 6-3 output display 9-25 Resistive Index, Doppler 5-6 PAL save to calculation and report 5-1 definition A-1 terminology 6-3 option 3-9 vascular 5-44 password 3-3–3-4, 3-6 Velocities, Doppler 5-6 patient header 2-11, 3-9 mechanical index (MI) 9-25, A-1 patient information form 4-19, 4-24–4-25 mitral valve/aortic valve (MV/AV) 5-22 patient list 4-23 M-line 4-5 patient report

B-5 about 5-45 PW Doppler. See pulsed wave (PW) Doppler cardiac 5-46 imaging general 5-46 recording problem 8-2 references OB 5-47 cardiac 6-4 save measurement to 5-1 general 6-18 vascular 5-46 gestational age tables 6-13 PC 3-9 growth analysis tables 6-16 pediatric, intended uses 2-19 obstetrical 6-12 percent reduction calculations 5-11 ratio calculations 6-18 peripherals 10-3 report, patient 5-45 compatible 9-14 5-6 pictographs resistive index (RI) measurement right ventricular systolic pressure PICTO key 2-11 (RVSP) 5-24 placing 4-19 safety power battery 9-8 AC 2-5 biological 9-10 cord 2-5 electrical 9-4 DC 2-5 electromagnetic compatibility 9-11 power delay 3-8 equipment 9-7 power key 2-9 save precision, acoustic measurement 9-74 calculations 5-9 preferences 3-13 image 2-10 presets 3-13 measurements 5-1 pressure half time (PHT) 5-24 SAVE key 3-13 pressure limits 10-3 scale 4-9 PRF 4-7, 4-9 scanhead. See transducer print 4-26 screen layout 2-11 printer security 3-2 problem 8-2 separation distance 9-13 setup 3-8 serial port 3-9 probe. See transducer setup pages 3-1 proximal isovelocity surface area (PISA) 5-18 ship pulsed wave (PW) Doppler imaging 4-7

B-6 transducer 7-12 status 2-11, 3-10 shipping specifications 10-3 wake up 2-6 shortcut keys 3-1 temperature limits 10-3 Simpson’s Rule 5-22 text 4-17 skin line, definition A-1 text description 2-11 sleep delay 3-8 thermal index (TI) 3-13, 9-25, A-2 small parts calculations 5-40 THI 4-3 software license 8-2 time setup 3-9 SonoHD A-2 tissue Doppler imaging (TDI) 4-9, 5-30 SonoMB 4-3, A-2 tissue models 9-28 spectral trace 4-8 touchpad 2-10, 2-14 stand, clean and disinfect 7-12 Transcranial Doppler calculations 5-41 standards transcranial, intended uses 2-19 acoustic 10-5 transducer electromechanical 10-4 connect 9-13 EMC classification 10-5 curved array A-1 HIPAA 10-6 definition A-2 steering exam type 4-14 CPD 4-7 general use 2-16 Doppler 4-9 imaging modes 4-14 storage commitment 3-8 invasive or surgical use 2-16 storage specifications linear array A-1 equipment 10-3 preparation 2-16 images 10-2 problems 8-2 stroke volume (SV) 5-27 ship 7-12 superficial, intended uses 2-19 specifications 10-1 sweep speed transport 7-11 Doppler 4-10 transport ECG 4-28 transducer 7-11 M Mode 4-5 troubleshoot 1-3, 8-1 symbols, labeling 9-75 ultrasound terminology A-1 system unfreeze text 3-7 controls 2-9 USB storage device, export to 4-26

B-7 user account 3-4 user guide conventions used 1-2 updates 1-2 user setup 3-3 uses, intended 2-18–2-20 variance 4-7 vascular calculations 5-44 intended uses 2-20 velocity measurement 5-6 velocity time integral (VTI) 5-24 volume Doppler, adjust 4-10 volume flow 5-14 wall filter 4-7, 4-10 warnings, definition 1-2 worklist 11-1 worksheets, EMED 5-48–5-49 zoom 4-11

B-8

P07662-06 *P07662-06*